GEL-FLOW NT
Report
- Report Number
- 1810189-2019-00045
- Event Type
- Malfunction
- Date Received
- June 13, 2019
- Report Date
- June 3, 2019
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHARMACIST
Narratives
REVIEW OF ALL RECORDS WITHIN SCOPE OF INVESTIGATION DEMONSTRATED ACCEPTABILITY OF PRODUCT OVER TIMEFRAME WITHIN SCOPE. WORST CASE SEVERITY FOR REPORTED MALFUNCTION DETERMINED FROM RISK DOCUMENTATION FOR PRODUCT WAS S4.BASED UPON RESULTS OF THIS INVESTIGATION, PGS-QO CONCLUDES THAT QUALITY OF PRODUCT ON MARKET REMAINS ACCEPTABLE. REVIEWED GEL-FLOW NT NCES AND NONE WOULD HAVE BEEN LIKELY ASSOCIATED WITH CAUSE OF ISSUE. REVIEWED GEL-FLOW NT COS AND NONE WERE IDENTIFIED THAT WOULD HAVE BEEN LIKELY ASSOCIATED WITH CAUSE OF THE ISSUE. THERE HAVE BEEN NO CHANGES TO STERILIZATION, EQUIPMENT, OR RAW MATERIALS (GELFOAM) THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PER RA 1438 RG, "MIXED POWDER DOES NOT HAVE HEMOSTATIC EFFECT ON BLEEDING SURFACES WITHIN USE PERIOD OF 4 HOURS" HAS TWO POTENTIAL CAUSES OF FAILURE:1)MIXED POWDER LOSES INTEGRITY WITHIN 4 HOURS OF BEING RECONSTITUTED - THIS IS UNKNOWN SINCE THERE ARE NO DETAILS ON HOW LONG BEFORE PRODUCT WAS USED AFTER BEING RECONSTITUTED. 2)POWDER DOES NOT HAVE CORRECT AMOUNT OF HEAT CROSS LINKING - EACH LOT IS INDIVIDUALLY REVIEW PER MP1512 TO ENSURE PRODUCT IS WITHIN TIME AND TEMPERATURE SPECIFICATION. ANY PRODUCT THAT DID NOT MEET THIS SPECIFICATION WOULD HAVE BEEN SCRAPPED. THERE WERE NO NCES INITIATED THAT MAY HAVE LED TO INITIAL COMPLAINT. BASED OFF THIS INFORMATION THE CAUSE OF THIS ISSUE IS UNDETERMINED AT THIS TIME AND THERE IS NO INTERNAL REQUIREMENT IDENTIFIED THAT WAS NOT MET. RISK ASSESSMENT: PER RA 1438 RG, "MIXED POWDER DOES NOT HAVE HEMOSTATIC EFFECT ON BLEEDING SURFACES WITHIN USE PERIOD OF 4 HOURS" HAS AN ASSOCIATED SEVERITY OF 3. PROBABLE CAUSE: BASED ON INFORMATION AND REVIEW OF DHF CAUSE OF INITIAL COMPLAINT IS UNKNOWN. NO ADDITIONAL ACTION TAKEN AT THIS TIME. IT WAS SUBSEQUENTLY DECIDED NOT TO REPEAT INVESTIGATION. FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. BASED ON COMPLAINT NARRATIVE, PATIENT USED GEL-FLOW PRODUCT TO STOP BLEEDING POST SURGICAL PROCEDURE BUT PRODUCT WAS INEFFECTIVE AND PATIENT CONTINUED TO BLEED.
ON (B)(6)2019, THE FOLLOWING WAS PROVIDED BY THE PRODUCT QUALITY COMPLAINT GROUP: A COMPLAINT HAS BEEN RECEIVED BY PFIZER (SITE NAME REDACTED) WITH REASONABLE MALFUNCTION WITH AN ASSOCIATED WORST CASE SEVERITY THAT IS UNKNOWN. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT; HAZARDOUS SITUATION: UNKNOWN; HAZARD NUMBER: UNKNOWN; P2 VALUES: UNKNOWN. ON FOLLOW-UP, THE PRODUCT QUALITY COMPLAINTS GROUP PROVIDED ADDITIONAL INFORMATION: THE EVENT OF "PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING" WAS MAPPED TO HAZARD H05-01 "PRODUCT DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS" WITH WORST SEVERITY LEVEL S4. P2 VALUE FOR A SEVERITY OF S4: 0.0526. PFIZER QUALITY OPERATIONS EXAMINED ELEVEN RETAINED REFERENCE CARTONS. THE CARTONS WERE LABELED GEL-FLOW, BATCH AG1206, EXP 31MAR2020. SIX CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632893, EXP. 08AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. THE REMAINING FIVE CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632894, EXP. 10AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. AS OF 23JUL2109, PGS QO DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE FOR EXAMINATION. ROOT CAUSE ANALYSIS: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT RELATED TO THE PRODUCTION PROCESS OF THE REPORTED BATCH. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN THE IDENTIFICATION OF A ROOT CAUSE. REVIEWED RETAINED REFERENCE SAMPLES WERE ACCEPTABLE IN APPEARANCE. A REVIEW OF ALL OTHER RECORDS, INCLUDING MANUFACTURING RECORDS AND QUALITY INSPECTIONS, FOR THIS PRODUCT INDICATED THAT THIS BATCH HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. CORRECT.
EVENT VERBATIM [PREFERRED TERM] DID NOT STOP BLEEDING IN ONE OF HIS CASES; PRODUCT DID NOT WORK TO STOP BLEEDING [DEVICE INEFFECTIVE]. CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM CONTACTABLE PHARMACIST VIA PFIZER SALES REPRESENTATIVE. THIS PHARMACIST REPORTED SAME EVENT FOR TWO PATIENTS, THIS IS THE 1ST OF THE TWO REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GEL-FLOW NT) (NDC NUMBER: (B)(4), LOT NUMBER: AG1206), EXPIRATION DATE : MAR2020, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSE FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHARMACIST REPORTED ONE OF THE NEUROSURGEONS HE SAW, SAID THAT ABSORBABLE GELATIN DID NOT STOP BLEEDING IN ONE OF HIS CASES; THE PRODUCT DID NOT WORK TO STOP BLEEDING. NO EVENT DETAILS WERE PROVIDED. THE ACTION TAKEN WITH ABSORBABLE GELATIN AND THE PATIENT OUTCOME WERE UNKNOWN. THE PFIZER SALES REPRESENTATIVE WAS PROVIDED WITH THE REFERENCE #(B)(4). ON 06JUN2019, THE FOLLOWING WAS PROVIDED BY THE PRODUCT QUALITY COMPLAINT GROUP: A COMPLAINT HAS BEEN RECEIVED BY PFIZER (SITE NAME REDACTED) WITH REASONABLE MALFUNCTION WITH AN ASSOCIATED WORST CASE SEVERITY THAT IS UNKNOWN. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT; HAZARDOUS SITUATION: UNKNOWN; HAZARD NUMBER: UNKNOWN; P2 VALUES: UNKNOWN. ON FOLLOW-UP, THE PRODUCT QUALITY COMPLAINTS GROUP PROVIDED ADDITIONAL INFORMATION: THE EVENT OF "PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING" WAS MAPPED TO HAZARD H05-01 "PRODUCT DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS" WITH WORST SEVERITY LEVEL S4. P2 VALUE FOR A SEVERITY OF S4: 0.0526. PFIZER QUALITY OPERATIONS EXAMINED ELEVEN RETAINED REFERENCE CARTONS. THE CARTONS WERE LABELED GEL-FLOW, BATCH AG1206, EXP 31MAR2020. SIX CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632893, EXP. 08AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. THE REMAINING FIVE CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632894, EXP. 10AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. FOLLOW-UP (06JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: NOTIFICATION COMPLAINT RECEIVED. FOLLOW-UP (13JUN2019 AND 15JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: HAZARD NUMBER, SEVERITY LEVEL, P2 VALUE. FOLLOW-UP (18JUL2019): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED: LOT NUMBER, EXPIRATION DATE, AND INVESTIGATION SUMMARY. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED.
DID NOT STOP BLEEDING IN ONE OF HIS CASES; PRODUCT DID NOT WORK TO STOP BLEEDING [DEVICE INEFFECTIVE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM CONTACTABLE PHARMACIST VIA PFIZER SALES REPRESENTATIVE. THIS PHARMACIST REPORTED SAME EVENT FOR TWO PATIENTS, THIS IS THE 1ST OF THE TWO REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GEL-FLOW NT) (NDC NUMBER: 0009-2250-01, LOT NUMBER: AG1206), EXPIRATION DATE : MAR2020, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSE FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHARMACIST REPORTED ONE OF THE NEUROSURGEONS HE SAW, SAID THAT ABSORBABLE GELATIN DID NOT STOP BLEEDING IN ONE OF HIS CASES; THE PRODUCT DID NOT WORK TO STOP BLEEDING. NO EVENT DETAILS WERE PROVIDED. THE ACTION TAKEN WITH ABSORBABLE GELATIN AND THE PATIENT OUTCOME WERE UNKNOWN. THE PFIZER SALES REPRESENTATIVE WAS PROVIDED WITH THE REFERENCE#: (B)(4). ON 06JUN2019, THE FOLLOWING WAS PROVIDED BY THE PRODUCT QUALITY COMPLAINT GROUP: A COMPLAINT HAS BEEN RECEIVED BY PFIZER (SITE NAME REDACTED) WITH REASONABLE MALFUNCTION WITH AN ASSOCIATED WORST CASE SEVERITY THAT IS UNKNOWN. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT; HAZARDOUS SITUATION: UNKNOWN; HAZARD NUMBER: UNKNOWN; P2 VALUES: UNKNOWN. ON FOLLOW-UP, THE PRODUCT QUALITY COMPLAINTS GROUP PROVIDED ADDITIONAL INFORMATION: THE EVENT OF "PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING" WAS MAPPED TO HAZARD H05-01 "PRODUCT DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS" WITH WORST SEVERITY LEVEL S4. P2 VALUE FOR A SEVERITY OF S4: 0.0526. PFIZER QUALITY OPERATIONS EXAMINED ELEVEN RETAINED REFERENCE CARTONS. THE CARTONS WERE LABELED GEL-FLOW, BATCH: AG1206, EXP: 31MAR2020. SIX CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH: 632893, EXP: 08AUG2021, A THROMBIN JMI KIT, LABELED BATCH: X43308, EXP: MAR2020 AND TWO PRODUCT INSERTS. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. THE REMAINING FIVE CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH: 632894, EXP: 10AUG2021, A THROMBIN JMI KIT, LABELED BATCH: X43308, EXP: MAR2020 AND TWO PRODUCT INSERTS. AS OF 23JUL2019, PGS QO DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE FOR EXAMINATION. ROOT CAUSE ANALYSIS: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT RELATED TO THE PRODUCTION PROCESS OF THE REPORTED BATCH. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN THE IDENTIFICATION OF A ROOT CAUSE. REVIEWED RETAINED REFERENCE SAMPLES WERE ACCEPTABLE IN APPEARANCE. A REVIEW OF ALL OTHER RECORDS, INCLUDING MANUFACTURING RECORDS AND QUALITY INSPECTIONS, FOR THIS PRODUCT INDICATED THAT THIS BATCH HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. CORRECTIVE/ PREVENTIVE ACTION: PFIZER QUALITY OPERATIONS AND PRODUCTION HAVE BEEN NOTIFIED WITH THE DETAILS OF THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE HAVE BEEN IDENTIFIED AS A RESULT OF THIS INVESTIGATION AT THIS TIME. THE RESULTS OF ALL TESTS, INSPECTIONS, AND IN-PROCESS CONTROLS HAVE BEEN REVIEWED AND ALL RESULTS MET THE ESTABLISHED REQUIREMENTS PRIOR TO THE RELEASE OF THE REPORTED BATCH FOR DISTRIBUTION. THE BATCH HISTORY FOR GELFOAM BATCH: AG1206 WITH COMPLAINT CLASSIFICATION 'PRODUCT USE ATTRIBUTES' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. AS OF 07JUN2019, A TOTAL OF ONE COMPLAINT HAS BEEN RECEIVED FOR THIS BATCH NUMBER AND CLASSIFICATION. NO BATCH SPECIFIC TREND WAS IDENTIFIED. MEDICAL DEVICE REPOT REVIEW: A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. THERE WERE NO PREVIOUS MDR RELEVANT TO THE REPORTED COMPLAINT; THEREFORE, THE REPORTED COMPLAINT WAS NOT ESCALATED TO PFIZER US SAFETY AS A REPEATED MDR OCCURRENCE. TREND ANALYSIS FROM 06JUN2016-05JUN2019: THE RESULTS OF THE ABOVE QUERY WERE FURTHER EVALUATED BY DATE CONTACTED, AND THEN ALSO BY THE CLASSIFICATION 'PRODUCT USE ATTRIBUTES' AND SUB-CLASSIFICATION OF 'LACK OF EFFECT'. THE REPORTED COMPLAINT IS THE SOLE COMPLAINT THAT HAS BEEN RECEIVED FOR THIS CLASS AND SUB-CLASS. NO NEGATIVE TREND IN REGARDS TO PRODUCT QUALITY WAS IDENTIFIED. A REVIEW OF COMPLAINTS RECEIVED WITH THE COMPLAINT CLASSIFICATION 'PRODUCT USE ATTRIBUTES' WAS PERFORMED FOR ALL BATCHES MANUFACTURED WITH THE SAME GEL-FLOW NT AND THROMBIN JMI KITS AS A PART OF THIS INVESTIGATION. A TOTAL OF ONE COMPLAINT HAS BEEN RECEIVED FOR THIS CLASSIFICATION RELATED TO PRODUCT MANUFACTURED WITH THE INVOLVED COMPONENT BATCHES. NO COMPONENT SPECIFIC TREND WAS IDENTIFIED. CONCLUSION: THE REVIEW OF ALL RECORDS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. THE WORST CASE SEVERITY FOR THE REPORTED MALFUNCTION DETERMINED FROM RISK DOCUMENTATION FOR THE PRODUCT WAS S4; THEREFORE, THE DETAILS OF THE REPORTED COMPLAINT WERE FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE PGS MDCP TEAM FOR EVALUATION. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THE FOLLOWING WAS THE INVESTIGATION SUMMARY PROVIDED ON 23JUL2019: REVIEWED GEL-FLOW NT NCES AND NONE WOULD HAVE BEEN LIKELY ASSOCIATED WITH THE CAUSE OF THE ISSUE. REVIEWED GEL-FLOW NT COS AND NONE WERE IDENTIFIED THAT WOULD HAVE BEEN LIKELY ASSOCIATED WITH THE CAUSE OF THE ISSUE. THERE HAVE BEEN NO CHANGES TO STERILIZATION, EQUIPMENT, OR RAW MATERIALS (GELFOAM) THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PER RA 1438 RG, "MIXED POWDER DOES NOT HAVE HEMOSTATIC EFFECT ON BLEEDING SURFACES WITHIN USE PERIOD OF 4 HOURS" HAS TWO POTENTIAL CAUSES OF FAILURE: 1) MIXED POWDER LOSES INTEGRITY WITHIN 4 HOURS OF BEING RECONSTITUTED - THIS IS UNKNOWN SINCE THERE ARE NO DETAILS ON HOW LONG BEFORE THE PRODUCT WAS USED AFTER BEING RECONSTITUTED. 2) POWDER DOES NOT HAVE CORRECT AMOUNT OF HEAT CROSS LINKING - EACH LOT IS INDIVIDUALLY REVIEW PER MP1512 TO ENSURE THE PRODUCT IS WITHIN TIME AND TEMPERATURE SPECIFICATION. ANY PRODUCT THAT DID NOT MEET THIS SPECIFICATION WOULD HAVE BEEN SCRAPPED. THERE WERE NO NCES INITIATED THAT MAY HAVE LED TO THE INITIAL COMPLAINT. BASED OFF THIS INFORMATION THE CAUSE OF THIS ISSUE IS UNDETERMINED AT THIS TIME AND THERE IS NO INTERNAL REQUIREMENT IDENTIFIED THAT WAS NOT MET. RISK ASSESSMENT: PER RA 1438 RG, "MIXED POWDER DOES NOT HAVE HEMOSTATIC EFFECT ON BLEEDING SURFACES WITHIN USE PERIOD OF 4 HOURS" HAS AN ASSOCIATED SEVERITY OF 3. PROBABLE CAUSE: BASED ON THE INFORMATION AND REVIEW OF THE DHF THE CAUSE OF THE INITIAL COMPLAINT IS UNKNOWN. NO ADDITIONAL ACTION TAKEN AT THIS TIME. WILL CONTINUE TO MONITOR. FOLLOW-UP (06JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: NOTIFICATION COMPLAINT RECEIVED. FOLLOW-UP (13JUN2019 AND 15JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: HAZARD NUMBER, SEVERITY LEVEL, P2 VALUE. FOLLOW-UP (18JUL2019): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED: LOT NUMBER, EXPIRATION DATE, AND INVESTIGATION SUMMARY. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (23JUL2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINTS INCLUDED INVESTIGATION RESULTS AND SUMMARY. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED., COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED.
EVENT VERBATIM [PREFERRED TERM] DID NOT STOP BLEEDING IN ONE OF HIS CASES; PRODUCT DID NOT WORK TO STOP BLEEDING [DEVICE INEFFECTIVE]. CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM CONTACTABLE PHARMACIST VIA PFIZER SALES REPRESENTATIVE. THIS PHARMACIST REPORTED SAME EVENT FOR TWO PATIENTS, THIS IS THE 1ST OF THE TWO REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GEL-FLOW NT) (NDC NUMBER:(B)(4), LOT NUMBER: AG1206), EXPIRATION DATE : MAR2020, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSE FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHARMACIST REPORTED ONE OF THE NEUROSURGEONS HE SAW, SAID THAT ABSORBABLE GELATIN DID NOT STOP BLEEDING IN ONE OF HIS CASES; THE PRODUCT DID NOT WORK TO STOP BLEEDING. NO EVENT DETAILS WERE PROVIDED. THE ACTION TAKEN WITH ABSORBABLE GELATIN AND THE PATIENT OUTCOME WERE UNKNOWN. THE PFIZER SALES REPRESENTATIVE WAS PROVIDED WITH THE REFERENCE #(B)(4). ON 06JUN2019, THE FOLLOWING WAS PROVIDED BY THE PRODUCT QUALITY COMPLAINT GROUP: A COMPLAINT HAS BEEN RECEIVED BY PFIZER (SITE NAME REDACTED) WITH REASONABLE MALFUNCTION WITH AN ASSOCIATED WORST CASE SEVERITY THAT IS UNKNOWN. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT; HAZARDOUS SITUATION: UNKNOWN; HAZARD NUMBER: UNKNOWN; P2 VALUES: UNKNOWN. ON FOLLOW-UP, THE PRODUCT QUALITY COMPLAINTS GROUP PROVIDED ADDITIONAL INFORMATION: THE EVENT OF "PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING" WAS MAPPED TO HAZARD H05-01 "PRODUCT DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS" WITH WORST SEVERITY LEVEL S4. P2 VALUE FOR A SEVERITY OF S4: 0.0526. PFIZER QUALITY OPERATIONS EXAMINED ELEVEN RETAINED REFERENCE CARTONS. THE CARTONS WERE LABELED GEL-FLOW, BATCH AG1206, EXPIRY 31MAR2020. SIX CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632893, EXP. 08AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. THE REMAINING FIVE CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632894, EXP. 10AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. AS OF 23JUL2109, PFIZER DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE FOR EXAMINATION. ROOT CAUSE ANALYSIS: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT RELATED TO THE PRODUCTION PROCESS OF THE REPORTED BATCH. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN THE IDENTIFICATION OF A ROOT CAUSE. REVIEWED RETAINED REFERENCE SAMPLES WERE ACCEPTABLE IN APPEARANCE. A REVIEW OF ALL OTHER RECORDS, INCLUDING MANUFACTURING RECORDS AND QUALITY INSPECTIONS, FOR THIS PRODUCT INDICATED THAT THIS BATCH HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. CORRECTIVE/ PREVENTIVE ACTION: PFIZER QUALITY OPERATIONS AND PRODUCTION HAVE BEEN NOTIFIED WITH THE DETAILS OF THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE HAVE BEEN IDENTIFIED AS A RESULT OF THIS INVESTIGATION AT THIS TIME. THE RESULTS OF ALL TESTS, INSPECTIONS, AND IN-PROCESS CONTROLS HAVE BEEN REVIEWED AND ALL RESULTS MET THE ESTABLISHED REQUIREMENTS PRIOR TO THE RELEASE OF THE REPORTED BATCH FOR DISTRIBUTION. THE BATCH HISTORY FOR GELFOAM BATCH AG1206 WITH COMPLAINT CLASSIFICATION 'PRODUCT USE ATTRIBUTES' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. AS OF 07JUN2019, A TOTAL OF ONE COMPLAINT HAS BEEN RECEIVED FOR THIS BATCH NUMBER AND CLASSIFICATION. NO BATCH SPECIFIC TREND WAS IDENTIFIED. MEDICAL DEVICE REPORT REVIEW: A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. THERE WERE NO PREVIOUS MDR RELEVANT TO THE REPORTED COMPLAINT; THEREFORE, THE REPORTED COMPLAINT WAS NOT ESCALATED TO PFIZER US SAFETY AS A REPEATED MDR OCCURRENCE. TREND ANALYSIS FROM 06JUN2016-05JUN2019: THE RESULTS OF THE ABOVE QUERY WERE FURTHER EVALUATED BY DATE CONTACTED, AND THEN ALSO BY THE CLASSIFICATION 'PRODUCT USE ATTRIBUTES' AND SUB-CLASSIFICATION OF 'LACK OF EFFECT'. THE REPORTED COMPLAINT IS THE SOLE COMPLAINT THAT HAS BEEN RECEIVED FOR THIS CLASS AND SUB-CLASS. NO NEGATIVE TREND IN REGARDS TO PRODUCT QUALITY WAS IDENTIFIED. A REVIEW OF COMPLAINTS RECEIVED WITH THE COMPLAINT CLASSIFICATION 'PRODUCT USE ATTRIBUTES' WAS PERFORMED FOR ALL BATCHES MANUFACTURED WITH THE SAME GEL-FLOW NT AND THROMBIN JMI KITS AS A PART OF THIS INVESTIGATION. A TOTAL OF ONE COMPLAINT HAS BEEN RECEIVED FOR THIS CLASSIFICATION RELATED TO PRODUCT MANUFACTURED WITH THE INVOLVED COMPONENT BATCHES. NO COMPONENT SPECIFIC TREND WAS IDENTIFIED. CONCLUSION: THE REVIEW OF ALL RECORDS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. THE WORST CASE SEVERITY FOR THE REPORTED MALFUNCTION DETERMINED FROM RISK DOCUMENTATION FOR THE PRODUCT WAS S4; THEREFORE, THE DETAILS OF THE REPORTED COMPLAINT WERE FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE PGS MDCP TEAM FOR EVALUATION. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THE FOLLOWING WAS THE INVESTIGATION SUMMARY PROVIDED ON 23JUL2109: REVIEWED GEL-FLOW NT NCES AND NONE WOULD HAVE BEEN LIKELY ASSOCIATED WITH THE CAUSE OF THE ISSUE. REVIEWED GEL-FLOW NT COS AND NONE WERE IDENTIFIED THAT WOULD HAVE BEEN LIKELY ASSOCIATED WITH THE CAUSE OF THE ISSUE. THERE HAVE BEEN NO CHANGES TO STERILIZATION, EQUIPMENT, OR RAW MATERIALS (GELFOAM) THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PER RA 1438 RG, "MIXED POWDER DOES NOT HAVE HEMOSTATIC EFFECT ON BLEEDING SURFACES WITHIN USE PERIOD OF 4 HOURS" HAS TWO POTENTIAL CAUSES OF FAILURE: 1) MIXED POWDER LOSES INTEGRITY WITHIN 4 HOURS OF BEING RECONSTITUTED - THIS IS UNKNOWN SINCE THERE ARE NO DETAILS ON HOW LONG BEFORE THE PRODUCT WAS USED AFTER BEING RECONSTITUTED. 2) POWDER DOES NOT HAVE CORRECT AMOUNT OF HEAT CROSS LINKING - EACH LOT IS INDIVIDUALLY REVIEW PER MP1512 TO ENSURE THE PRODUCT IS WITHIN TIME AND TEMPERATURE SPECIFICATION. ANY PRODUCT THAT DID NOT MEET THIS SPECIFICATION WOULD HAVE BEEN SCRAPPED. THERE WERE NO NCES INITIATED THAT MAY HAVE LED TO THE INITIAL COMPLAINT. BASED OFF THIS INFORMATION THE CAUSE OF THIS ISSUE IS UNDETERMINED AT THIS TIME AND THERE IS NO INTERNAL REQUIREMENT IDENTIFIED THAT WAS NOT MET. RISK ASSESSMENT: PER RA 1438 RG, "MIXED POWDER DOES NOT HAVE HEMOSTATIC EFFECT ON BLEEDING SURFACES WITHIN USE PERIOD OF 4 HOURS" HAS AN ASSOCIATED SEVERITY OF 3. PROBABLE CAUSE: BASED ON THE INFORMATION AND REVIEW OF THE DHF THE CAUSE OF THE INITIAL COMPLAINT IS UNKNOWN. NO ADDITIONAL ACTION TAKEN AT THIS TIME. WILL CONTINUE TO MONITOR. ON 23MAR2020 AND 24MAR2020, THE PRODUCT QUALITY COMPLAINT GROUP PROVIDED ADDITIONAL INVESTIGATION RESULTS AS FOLLOWS. REASONABLY SUGGEST DEVICE MALFUNCTION WAS CONFIRMED AS YES AND SEVERITY OF HARM WAS CONFIRMED AS S4. IT WAS DECIDED NOT TO REPEAT THE INVESTIGATION. THE FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. SUMMARY OF INVESTIGATION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT USED GEL-FLOW PRODUCT TO STOP BLEEDING POST A SURGICAL PROCEDURE BUT THE PRODUCT WAS INEFFECTIVE AND THE PATIENT CONTINUED TO BLEED. FOLLOW-UP (06JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: NOTIFICATION COMPLAINT RECEIVED. FOLLOW-UP (13JUN2019 AND 15JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: HAZARD NUMBER, SEVERITY LEVEL, P2 VALUE. FOLLOW-UP (18JUL2019): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED: LOT NUMBER, EXPIRATION DATE, AND INVESTIGATION SUMMARY. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (23JUL2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINTS INCLUDED INVESTIGATION RESULTS AND SUMMARY. FOLLOW-UP (12AUG2019): FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (08OCT2019): THE PRODUCT QUALITY COMPLAINT GROUP CONFIRMS THE CASE REMAINS A MALFUNCTION REPORT. FOLLOW-UP (23MAR2020 AND 24MAR2020): NEW INFORMATION FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED: ADDITIONAL INVESTIGATION RESULTS. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. THE FOLLOW-UP INFORMATION RECEIVED DOES NOT ALTER THE PREVIOUS COMPANY CLINICAL EVALUATION.
EVENT VERBATIM, DID NOT STOP BLEEDING IN ONE OF HIS CASES; PRODUCT DID NOT WORK TO STOP BLEEDING (DEVICE INEFFECTIVE). CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM CONTACTABLE PHARMACIST VIA PFIZER SALES REPRESENTATIVE. THIS PHARMACIST REPORTED SAME EVENT FOR TWO PATIENTS, THIS IS THE 1ST OF THE TWO REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GEL-FLOW NT) (NDC NUMBER: 0009-2250-01), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSE FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHARMACIST REPORTED ONE OF THE NEUROSURGEONS HE SAW, SAID THAT ABSORBABLE GELATIN DID NOT STOP BLEEDING IN ONE OF HIS CASES; THE PRODUCT DID NOT WORK TO STOP BLEEDING. NO EVENT DETAILS WERE PROVIDED. THE ACTION TAKEN WITH ABSORBABLE GELATIN AND THE PATIENT OUTCOME WERE UNKNOWN. THE PFIZER SALES REPRESENTATIVE WAS PROVIDED WITH THE REFERENCE #(B)(4). ON 06JUN2019, THE FOLLOWING WAS PROVIDED BY THE PRODUCT QUALITY COMPLAINT GROUP: A COMPLAINT HAS BEEN RECEIVED BY PFIZER (SITE NAME REDACTED) WITH REASONABLE MALFUNCTION WITH AN ASSOCIATED WORST CASE SEVERITY THAT IS UNKNOWN. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT; HAZARDOUS SITUATION: UNKNOWN; HAZARD NUMBER: UNKNOWN; P2 VALUES: UNKNOWN. ON FOLLOW-UP, THE PRODUCT QUALITY COMPLAINTS GROUP PROVIDED ADDITIONAL INFORMATION: THE EVENT OF "PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING" WAS MAPPED TO HAZARD H05-01 "PRODUCT DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS" WITH WORST SEVERITY LEVEL S4. P2 VALUE FOR A SEVERITY OF S4: 0.0526. FOLLOW-UP (06JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: NOTIFICATION COMPLAINT RECEIVED. FOLLOW-UP (13JUN2019 AND 15JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: HAZARD NUMBER, SEVERITY LEVEL, P2 VALUE. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED. COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED.
EVENT VERBATIM [PREFERRED TERM] DID NOT STOP BLEEDING IN ONE OF HIS CASES; PRODUCT DID NOT WORK TO STOP BLEEDING [DEVICE INEFFECTIVE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM CONTACTABLE PHARMACIST VIA PFIZER SALES REPRESENTATIVE. THIS PHARMACIST REPORTED SAME EVENT FOR TWO PATIENTS, THIS IS THE 1ST OF THE TWO REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GEL-FLOW NT) (NDC NUMBER: 0009-2250-01, LOT NUMBER: AG1206), EXPIRATION DATE : MAR2020, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSE FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHARMACIST REPORTED ONE OF THE NEUROSURGEONS HE SAW, SAID THAT ABSORBABLE GELATIN DID NOT STOP BLEEDING IN ONE OF HIS CASES; THE PRODUCT DID NOT WORK TO STOP BLEEDING. NO EVENT DETAILS WERE PROVIDED. THE ACTION TAKEN WITH ABSORBABLE GELATIN AND THE PATIENT OUTCOME WERE UNKNOWN. THE PFIZER SALES REPRESENTATIVE WAS PROVIDED WITH THE REFERENCE #Z4UHB1NJ. ON 06JUN2019, THE FOLLOWING WAS PROVIDED BY THE PRODUCT QUALITY COMPLAINT GROUP: A COMPLAINT HAS BEEN RECEIVED BY PFIZER (SITE NAME REDACTED) WITH REASONABLE MALFUNCTION WITH AN ASSOCIATED WORST CASE SEVERITY THAT IS UNKNOWN. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT; HAZARDOUS SITUATION: UNKNOWN; HAZARD NUMBER: UNKNOWN; P2 VALUES: UNKNOWN. ON FOLLOW-UP, THE PRODUCT QUALITY COMPLAINTS GROUP PROVIDED ADDITIONAL INFORMATION: THE EVENT OF "PRODUCT DID NOT WORK TO STOP BLEEDING/ IT DID NOT STOP BLEEDING" WAS MAPPED TO HAZARD H05-01 "PRODUCT DOES NOT EFFECTIVELY PROMOTE HEMOSTASIS" WITH WORST SEVERITY LEVEL S4. P2 VALUE FOR A SEVERITY OF S4: 0.0526. PFIZER QUALITY OPERATIONS EXAMINED ELEVEN RETAINED REFERENCE CARTONS. THE CARTONS WERE LABELED GEL-FLOW, BATCH AG1206, EXP 31MAR2020. SIX CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632893, EXP. 08AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. NO PRODUCT QUALITY DEFECTS WERE OBSERVED. THE REMAINING FIVE CARTONS CONTAINED A GEL-FLOW NT PEEL POUCH, CONTAINING A PRE-FILLED SYRINGE OF GELFOAM POWDER, LABELED WITH BATCH 632894, EXP. 10AUG2021, A THROMBIN JMI KIT, LABELED BATCH X43308, EXP. MAR2020 AND TWO PRODUCT INSERTS. AS OF 23JUL2109, PGS QO DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE FOR EXAMINATION. ROOT CAUSE ANALYSIS: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT RELATED TO THE PRODUCTION PROCESS OF THE REPORTED BATCH. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN THE IDENTIFICATION OF A ROOT CAUSE. REVIEWED RETAINED REFERENCE SAMPLES WERE ACCEPTABLE IN APPEARANCE. A REVIEW OF ALL OTHER RECORDS, INCLUDING MANUFACTURING RECORDS AND QUALITY INSPECTIONS, FOR THIS PRODUCT INDICATED THAT THIS BATCH HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. CORRECTIVE/ PREVENTIVE ACTION: PFIZER QUALITY OPERATIONS AND PRODUCTION HAVE BEEN NOTIFIED WITH THE DETAILS OF THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE HAVE BEEN IDENTIFIED AS A RESULT OF THIS INVESTIGATION AT THIS TIME. THE RESULTS OF ALL TESTS, INSPECTIONS, AND IN-PROCESS CONTROLS HAVE BEEN REVIEWED AND ALL RESULTS MET THE ESTABLISHED REQUIREMENTS PRIOR TO THE RELEASE OF THE REPORTED BATCH FOR DISTRIBUTION. THE BATCH HISTORY FOR GELFOAM BATCH AG1206 WITH COMPLAINT CLASSIFICATION 'PRODUCT USE ATTRIBUTES' HAS BEEN EVALUATED FOR POTENTIAL TRENDS. AS OF 07JUN2019, A TOTAL OF ONE COMPLAINT HAS BEEN RECEIVED FOR THIS BATCH NUMBER AND CLASSIFICATION. NO BATCH SPECIFIC TREND WAS IDENTIFIED. MEDICAL DEVICE REPOT REVIEW: A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. THERE WERE NO PREVIOUS MDR RELEVANT TO THE REPORTED COMPLAINT; THEREFORE, THE REPORTED COMPLAINT WAS NOT ESCALATED TO PFIZER US SAFETY AS A REPEATED MDR OCCURRENCE. TREND ANALYSIS FROM 06JUN2016-05JUN2019: THE RESULTS OF THE ABOVE QUERY WERE FURTHER EVALUATED BY DATE CONTACTED, AND THEN ALSO BY THE CLASSIFICATION 'PRODUCT USE ATTRIBUTES' AND SUB-CLASSIFICATION OF 'LACK OF EFFECT'. THE REPORTED COMPLAINT IS THE SOLE COMPLAINT THAT HAS BEEN RECEIVED FOR THIS CLASS AND SUB-CLASS. NO NEGATIVE TREND IN REGARDS TO PRODUCT QUALITY WAS IDENTIFIED. A REVIEW OF COMPLAINTS RECEIVED WITH THE COMPLAINT CLASSIFICATION 'PRODUCT USE ATTRIBUTES' WAS PERFORMED FOR ALL BATCHES MANUFACTURED WITH THE SAME GEL-FLOW NT AND THROMBIN JMI KITS AS A PART OF THIS INVESTIGATION. A TOTAL OF ONE COMPLAINT HAS BEEN RECEIVED FOR THIS CLASSIFICATION RELATED TO PRODUCT MANUFACTURED WITH THE INVOLVED COMPONENT BATCHES. NO COMPONENT SPECIFIC TREND WAS IDENTIFIED. CONCLUSION: THE REVIEW OF ALL RECORDS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. THE WORST CASE SEVERITY FOR THE REPORTED MALFUNCTION DETERMINED FROM RISK DOCUMENTATION FOR THE PRODUCT WAS S4; THEREFORE, THE DETAILS OF THE REPORTED COMPLAINT WERE FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE PGS MDCP TEAM FOR EVALUATION. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THE FOLLOWING WAS THE INVESTIGATION SUMMARY PROVIDED ON 23JUL2109: REVIEWED GEL-FLOW NT NCES AND NONE WOULD HAVE BEEN LIKELY ASSOCIATED WITH THE CAUSE OF THE ISSUE. REVIEWED GEL-FLOW NT COS AND NONE WERE IDENTIFIED THAT WOULD HAVE BEEN LIKELY ASSOCIATED WITH THE CAUSE OF THE ISSUE. THERE HAVE BEEN NO CHANGES TO STERILIZATION, EQUIPMENT, OR RAW MATERIALS (GELFOAM) THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PER RA 1438 RG, "MIXED POWDER DOES NOT HAVE HEMOSTATIC EFFECT ON BLEEDING SURFACES WITHIN USE PERIOD OF 4 HOURS" HAS TWO POTENTIAL CAUSES OF FAILURE: 1) MIXED POWDER LOSES INTEGRITY WITHIN 4 HOURS OF BEING RECONSTITUTED - THIS IS UNKNOWN SINCE THERE ARE NO DETAILS ON HOW LONG BEFORE THE PRODUCT WAS USED AFTER BEING RECONSTITUTED. 2) POWDER DOES NOT HAVE CORRECT AMOUNT OF HEAT CROSS LINKING - EACH LOT IS INDIVIDUALLY REVIEW PER MP1512 TO ENSURE THE PRODUCT IS WITHIN TIME AND TEMPERATURE SPECIFICATION. ANY PRODUCT THAT DID NOT MEET THIS SPECIFICATION WOULD HAVE BEEN SCRAPPED. THERE WERE NO NCES INITIATED THAT MAY HAVE LED TO THE INITIAL COMPLAINT. BASED OFF THIS INFORMATION THE CAUSE OF THIS ISSUE IS UNDETERMINED AT THIS TIME AND THERE IS NO INTERNAL REQUIREMENT IDENTIFIED THAT WAS NOT MET. RISK ASSESSMENT: PER RA 1438 RG, "MIXED POWDER DOES NOT HAVE HEMOSTATIC EFFECT ON BLEEDING SURFACES WITHIN USE PERIOD OF 4 HOURS" HAS AN ASSOCIATED SEVERITY OF 3. PROBABLE CAUSE: BASED ON THE INFORMATION AND REVIEW OF THE DHF THE CAUSE OF THE INITIAL COMPLAINT IS UNKNOWN. NO ADDITIONAL ACTION TAKEN AT THIS TIME. WILL CONTINUE TO MONITOR. FOLLOW-UP (06JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: NOTIFICATION COMPLAINT RECEIVED. FOLLOW-UP (13JUN2019 AND 15JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: HAZARD NUMBER, SEVERITY LEVEL, P2 VALUE. FOLLOW-UP (18JUL2019): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED: LOT NUMBER, EXPIRATION DATE, AND INVESTIGATION SUMMARY. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (23JUL2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINTS INCLUDED INVESTIGATION RESULTS AND SUMMARY. FOLLOW-UP (12AUG2019): FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (08OCT2019): THE PRODUCT QUALITY COMPLAINT GROUP CONFIRMS THE CASE REMAINS A MALFUNCTION REPORT. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED., COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR. THE FOLLOW-UP INFORMATION RECEIVED DOES NOT ALTER THE PREVIOUS COMPANY CLINICAL EVALUATION.
EVENT VERBATIM [PREFERRED TERM] DID NOT STOP BLEEDING IN ONE OF HIS CASES; PRODUCT DID NOT WORK TO STOP BLEEDING [DEVICE INEFFECTIVE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM CONTACTABLE PHARMACIST VIA (B)(6) SALES REPRESENTATIVE. THIS PHARMACIST REPORTED SAME EVENT FOR TWO PATIENTS, THIS IS THE 1ST OF THE TWO REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GEL-FLOW NT) (NDC NUMBER: (B)(4)), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSE FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHARMACIST MENTIONED THAT HE HAD SEEN THAT FROM ONE OF THE NEUROSURGEON SAID THAT ABSORBABLE GELATIN DID NOT STOP BLEEDING IN ONE OF HIS CASES; PRODUCT DID NOT WORK TO STOP BLEEDING. THE ACTION TAKEN AND OUTCOME WAS UNKNOWN. (B)(6) SALES REPRESENTATIVE WAS PROVIDED WITH THE REFERENCE #: (B)(4). COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR., COMMENT: THE REPORTED EVENT CODED AS "DEVICE INEFFECTIVE" DID NOT CAUSE SERIOUS INJURY IN THIS PATIENT. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE PROLONGED BLEEDING DURING SURGERY OR POST-OPERATIVE BLEEDING, IF IT WERE TO RECUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 491757 | GEL-FLOW NT | POWDER, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) | AG1206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |