GELFOAM
Report
- Report Number
- 1810189-2023-00007
- Event Type
- Death
- Date Received
- April 19, 2023
- Report Date
- April 11, 2023
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(PARENT) FPRS EVALUATION COMMENT: PFIZER SITE AGREES WITH THE INVESTIGATION DECISION, CLASSIFICATION, SUB-CLASSIFICATION, PRIORITY, AND JUSTIFICATION. SITE ASSIGNMENT TABLE WAS REVIEWED AND IS ACCURATE AND APPROPRIATE. AN INVESTIGATION WILL BE PERFORMED. QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. SEVERITY AND REGULATORY REPORTABILITY ARE ASSESSED BY THE DCHU. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REQUIRING ESCALATION. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. THE COMPLAINT AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND IT WAS DETERMINED THAT OUR CONTAINMENT ACTION IS A NOTIFICATION TO MANAGEMENT. A FULL INVESTIGATION WILL BE PERFORMED. THIS IS A COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM. THE INVESTIGATION WILL INCLUDE A REVIEW OF COMPLAINTS WITH KNOWN BATCH NUMBERS DETERMINED TO BE WITHIN SCOPE. SUMMARY OF INVESTIGATION: AN ADVERSE EVENT MD/MDCP COMPLAINT WAS RECEIVED FOR AN UNKNOWN LOT OF GELFOAM. REVIEW OF COMPLAINTS FOR GELFOAM SPONGE AND POWDER RECEIVED WITHIN 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. NO PREVIOUS COMPLAINTS WITH A KNOWN BATCH NUMBER WERE IDENTIFIED. EXISTING PROCESS CONTROLS, SUCH AS USE OF A SPECIFIC VALIDATED FORMULATION RECIPE AND AUTOMATIC RECORDING OF ALL WEIGHTS AND IDENTITIES OF RAW MATERIALS, DOCUMENTATION AND VERIFICATION OF CRITICAL FORMULATION, PROCESSING, AND STERILIZATION STEPS, AND FINAL RELEASE TESTING OF EACH BATCH TO ASSURE THAT IT MEETS ALL INTERNAL TARGETS AND REGISTERED SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION WERE REVIEWED AS A PART OF THIS INVESTIGATION. NO TRENDS WERE NOTED THAT WOULD REQUIRE ADDITIONAL INVESTIGATION. NO RETURNED COMPLAINT SAMPLE WAS RECEIVED. FINAL CONFIRMATION STATUS: NOT CONFIRMED. ROOT CAUSE ANALYSIS/IDENTIF: PFIZER SITE QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. IMPACT ANALYSIS: A SEVERITY HAS YET TO BE ISSUED FOR THIS COMPLAINT. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE FINAL DETERMINED SCOPE AND THE INABILITY TO DETERMINE A ROOT CAUSE FOR THE REPORTED COMPLAINT, PGS-QO SITE CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE IS NO IMPACT TO THE QUALITY OF THE PRODUCT. SPECIAL OR COMMON CAUSE: COMMON CAUSE ROOT CAUSE IS ALWAYS PRESENT TO SOME DEGREE IN THE PROCESS. SPECIAL CAUSE ROOT CAUSE IS SOMETHING DIFFERENT HAPPENING AT A CERTAIN TIME OR PLACE IN THE PROCESS. CORRECTIVE / PREVENTIVE ACTION: INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE SITE MDCP TEAM FOR REVIEW. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER SITE WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY.' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER SITE WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. SCOPE OF COMPL. THE INITIAL SCOPE OF THIS INVESTIGATION IS LIMITED TO A REVIEW OF COMPLAINTS WITH KNOWN BATCH NUMBERS RECEIVED WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL FOR THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED BECAUSE ANY PRODUCT ON THE MARKET WITHIN EXPIRY WOULD BE CAPTURED WITHIN THAT TIMEFRAME. A QUERY OF THE COMPLAINTS DATABASE FOR THE REPORTED PRODUCT, CLASS, AND SUB-LASS CAPTURED THE REQUIRED 5 DATA POINTS FOR THE REPORTED PRODUCT, CLASS, AND SUB-CLASS. OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. THE FINAL SCOPE WAS NOT EXPANDED AS A RESULT OF INVESTIGATION. DOCUMENT REVIEW SUMMARY: DEVIATIONS: A REVIEW OF DEVIATIONS, LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS COULD NOT BE PERFORMED FOR THE REPORTED COMPLAINT, AS THE BATCH IS UNKNOWN. MANUFACTURING/PACKAGING RECORDS: COMPLETE - ACCEPTABLE A REVIEW OF MANUFACTURING AND PACKAGING RECORDS COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, A REVIEW OF BATCH RECORDS FROM THE PREVIOUSLY INVESTIGATED COMPLAINTS DETERMINED TO BE IN SCOPE COULD NOT BE PERFORMED, AS THERE WERE NO COMPLAINTS WITH A KNOWN BATCH. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED THROUGH A FILTER WITH NITROGEN TO EXTRUDE THE LARGE, SOLID SPONGE BRICKS. THE BRICKS ARE DRIED, TRIMMED AND SPLIT. THE SPLIT BRICKS ARE THEN MILLED TO FORM POWDER. THE POWDER IS COLLECTED IN HIGH DENSITY POLYETHYLENE BAGS AND THEN SEALED INTO BULK CONTAINERS. THE GELFOAM POWDER IS THEN FILLED INTO INNER ENVELOPES USING A POWDER FILLING DEVICE. EACH ENVELOPE IS FILLED WITH A TARGET OF 1.2 GRAMS PER ENVELOPE AND A MINIMUM OF 1.0 GRAM PER ENVELOPE. TWO WEIGHT CHECKS OF EACH POWDER FILLING DEVICE ARE CONDUCTED AT 30-MINUTE INTERVALS TO ASSURE THAT THE DEVICE IS DISPENSING THE PROPER AMOUNT OF POWDER. THE FINAL PRODUCT YIELD IS CALCULATED AGAINST LIMITS FOR THE PRODUCT. THE INNER ENVELOPES ARE FOLDED OVER TWICE AND INSERTED INTO SLEEVES. THE FILLED SLEEVES ARE PLACED INTO TRAYS. THE SLEEVES (PEEL POUCHES) ARE SEALED, AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE ENVELOPES HAVE THE PROPER APPEARANCE, SEAL AND PRINT, AND ALL NOTED DEFECTIVE PRODUCT IS REMOVED FROM THE LOT PRIOR TO FINAL PACKAGING AND NO OPEN SIDE SEALS WERE OBSERVED. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. FOR GELFOAM SPONGE, THE BILL OF MATERIALS LISTS THE SPECIFIC PRODUCT COMPONENTS AND WEIGHTS REQUIRED FOR THE FORMULATION OF EACH BATCH. ALL MANUFACTURING MIXING SPEEDS, TIMES, AND TEMPERATURES HAVE SPECIFICATION CRITERIA. ALL EXTRUSION PARAMETERS HAVE REQUIRED SPECIFICATIONS. AFTER THE PRODUCT IS EXTRUDED INTO BRICKS, THE BRICKS ARE INSPECTED PRIOR TO BEING SLICED INTO INDIVIDUAL SPONGES. AFTER THE BRICKS ARE SLICED INTO SPONGES, A VISUAL INSPECTION IS PERFORMED FOR CONSISTENCY, UNIFORMITY, SHAPE, AND SIZE AT THE BEGINNING, MIDDLE, AND END OF SHIFTS AND EVERY FOUR HOURS IN BETWEEN. ALL DEFECTIVE SPONGES ARE IDENTIFIED AND REMOVED. THE GELFOAM IS PLACED INTO INNER ENVELOPES AND TRANSFERRED TO THE DOYEN PACKAGING EQUIPMENT TO PACKAGE THE ENVELOPES INTO PEEL POUCHES. THE DOYEN TAKES SIX ENVELOPES PER ROTATION BY SUCTION AND LOADS THEM ONTO A CONVEYER BELT AGAINST AN ALIGNMENT TAB. TWO OPERATORS SIT AT THE DOYEN TO CORRECT ALIGNMENT ISSUES PRIOR TO SEALING. THE FRONT AND BACK PAPERS, WHICH MAKE UP THE OUTER PEEL POUCH, ENCLOSE EACH INDIVIDUAL INNER ENVELOPE ENTIRELY WITH A FOUR-SIDED, HEAT-ACTIVATED ADHESIVE SEAL. THE TOP, BOTTOM, AND SIDES OF THE OUTER PEEL POUCHES ARE SEALED BY THREE DIFFERENT PARTS OF THE DOYEN WHICH EACH HAVE SEPARATE TEMPERATURE CONTROLS. EACH TEMPERATURE CONTROL IS VERIFIED AND DOCUMENTED IN THE BATCH RECORD. THE PEEL POUCHES ARE SEALED, AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE PEEL POUCHES HAVE THE PROPER APPEARANCE, SEAL AND PRINT. A SEAL INTEGRITY TEST (SIT) IS UTILIZED THROUGHOUT THE FINAL PACKAGING TO ENSURE THE SIDE SEALS OF THE PEEL POUCHES ARE ACCEPTABLE. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. AUDITS ARE PERFORMED ON THE FINISHED PACKAGED UNITS AT REGULAR INTERVALS THROUGHOUT THE FINAL PACKAGING PROCESS. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS, SUCH AS USE OF A SPECIFIC VALIDATED FORMULATION RECIPE AND AUTOMATIC RECORDING OF ALL WEIGHTS AND IDENTITIES OF RAW MATERIALS, DOCUMENTATION AND VERIFICATION OF CRITICAL FORMULATION, PROCESSING.
EVENT VERBATIM [PREFERRED TERM] IN 1 PATIENT, DEATH WAS RELATED TO EXCESSIVE AND SUDDEN BLOOD LOSS/DIED IN THE EARLY POSTOPERATIVE PERIOD, RELATED TO EXCESSIVE BLEEDING [POST PROCEDURAL HAEMORRHAGE], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "CAVERNOUS HEMANGIOMA OF CAVERNOUS SINUS: AN OUTCOME REPORT OF 45 SURGICALLY TREATED PATIENTS", WORLD NEUROSURGERY, 2022; VOL:159, PGS:381-389, DOI:(B)(6). A PATIENT (NO QUALIFIERS PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM, PFIZER INC, NEWYORK, USA), FOR HAEMOSTASIS. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "CAVERNOUS HEMANGIOMA OF CAVERNOUS SINUS" (UNSPECIFIED IF ONGOING); "HEADACHE" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: POST PROCEDURAL HAEMORRHAGE (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "IN 1 PATIENT, DEATH WAS RELATED TO EXCESSIVE AND SUDDEN BLOOD LOSS/DIED IN THE EARLY POSTOPERATIVE PERIOD, RELATED TO EXCESSIVE BLEEDING". THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "IN 1 PATIENT, DEATH WAS RELATED TO EXCESSIVE AND SUDDEN BLOOD LOSS". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED AND THE KNOWN SAFETY PROFILE, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED ADVERSE EVENT (POST PROCEDURAL HEMORRHAGE) AND THE SUSPECT PRODUCT (GELFOAM) CANNOT BE CLEARLY ESTABLISHED AND CANNOT BE EXCLUDED. IT WAS NOTED THAT "ONE PATIENT DIED OF POSTOPERATIVE BLEEDING IN THE TUMOR CAVITY". THIS CASE WILL BE REASSESSED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
EVENT VERBATIM [PREFERRED TERM]: IN 1 PATIENT, DEATH WAS RELATED TO EXCESSIVE AND SUDDEN BLOOD LOSS/DIED IN THE EARLY POSTOPERATIVE PERIOD, RELATED TO EXCESSIVE BLEEDING [POST PROCEDURAL HAEMORRHAGE], , NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "CAVERNOUS HEMANGIOMA OF CAVERNOUS SINUS: AN OUTCOME REPORT OF 45 SURGICALLY TREATED PATIENTS", WORLD NEUROSURGERY, 2022; VOL:159, PGS:381-389, DOI:10.1016/J.WNEU.2021.09.120. A PATIENT (NO QUALIFIERS PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM, PFIZER INC, NEWYORK, USA), FOR HAEMOSTASIS. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "CAVERNOUS HEMANGIOMA OF CAVERNOUS SINUS" (UNSPECIFIED IF ONGOING); "HEADACHE" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: POST PROCEDURAL HAEMORRHAGE (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "IN 1 PATIENT, DEATH WAS RELATED TO EXCESSIVE AND SUDDEN BLOOD LOSS/DIED IN THE EARLY POSTOPERATIVE PERIOD, RELATED TO EXCESSIVE BLEEDING". THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "IN 1 PATIENT, DEATH WAS RELATED TO EXCESSIVE AND SUDDEN BLOOD LOSS". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE REPORTER CONSIDERED "IN 1 PATIENT, DEATH WAS RELATED TO EXCESSIVE AND SUDDEN BLOOD LOSS/DIED IN THE EARLY POSTOPERATIVE PERIOD, RELATED TO EXCESSIVE BLEEDING" ASSOCIATED TO ABSORBABLE GELATIN. CAUSALITY FOR "IN 1 PATIENT, DEATH WAS RELATED TO EXCESSIVE AND SUDDEN BLOOD LOSS/DIED IN THE EARLY POSTOPERATIVE PERIOD, RELATED TO EXCESSIVE BLEEDING" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 07DEC2023 FOR ABSORBABLE GELATIN: THE CONCLUSION HAS REPORTED AS RELATED TO POTENTIAL ADVERSE EVENT(S) HAS/HAVE BEEN APPROVED/CLOSED. (PARENT) FPRS EVALUATION COMMENT: PFIZER SITE AGREES WITH THE INVESTIGATION DECISION, CLASSIFICATION, SUB-CLASSIFICATION, PRIORITY, AND JUSTIFICATION. SITE ASSIGNMENT TABLE WAS REVIEWED AND IS ACCURATE AND APPROPRIATE. AN INVESTIGATION WILL BE PERFORMED. QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. SEVERITY AND REGULATORY REPORTABILITY ARE ASSESSED BY THE DCHU. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REQUIRING ESCALATION. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. THE COMPLAINT AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND IT WAS DETERMINED THAT OUR CONTAINMENT ACTION IS A NOTIFICATION TO MANAGEMENT. A FULL INVESTIGATION WILL BE PERFORMED. THIS IS A COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM. THE INVESTIGATION WILL INCLUDE A REVIEW OF COMPLAINTS WITH KNOWN BATCH NUMBERS DETERMINED TO BE WITHIN SCOPE. SUMMARY OF INVESTIGATION: AN ADVERSE EVENT MD/MDCP COMPLAINT WAS RECEIVED FOR AN UNKNOWN LOT OF GELFOAM. REVIEW OF COMPLAINTS FOR GELFOAM SPONGE AND POWDER RECEIVED WITHIN 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. NO PREVIOUS COMPLAINTS WITH A KNOWN BATCH NUMBER WERE IDENTIFIED. EXISTING PROCESS CONTROLS, SUCH AS USE OF A SPECIFIC VALIDATED FORMULATION RECIPE AND AUTOMATIC RECORDING OF ALL WEIGHTS AND IDENTITIES OF RAW MATERIALS, DOCUMENTATION AND VERIFICATION OF CRITICAL FORMULATION, PROCESSING, AND STERILIZATION STEPS, AND FINAL RELEASE TESTING OF EACH BATCH TO ASSURE THAT IT MEETS ALL INTERNAL TARGETS AND REGISTERED SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION WERE REVIEWED AS A PART OF THIS INVESTIGATION. NO TRENDS WERE NOTED THAT WOULD REQUIRE ADDITIONAL INVESTIGATION. NO RETURNED COMPLAINT SAMPLE WAS RECEIVED. FINAL CONFIRMATION STATUS: NOT CONFIRMED. ROOT CAUSE ANALYSIS/IDENTIF: PFIZER SITE QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. IMPACT ANALYSIS: A SEVERITY HAS YET TO BE ISSUED FOR THIS COMPLAINT. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE FINAL DETERMINED SCOPE AND THE INABILITY TO DETERMINE A ROOT CAUSE FOR THE REPORTED COMPLAINT, PGS-QO SITE CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE IS NO IMPACT TO THE QUALITY OF THE PRODUCT. SPECIAL OR COMMON CAUSE: COMMON CAUSE ROOT CAUSE IS ALWAYS PRESENT TO SOME DEGREE IN THE PROCESS. SPECIAL CAUSE ROOT CAUSE IS SOMETHING DIFFERENT HAPPENING AT A CERTAIN TIME OR PLACE IN THE PROCESS. CORRECTIVE / PREVENTIVE ACTION: INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE SITE MDCP TEAM FOR REVIEW. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER SITE WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY.' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER SITE WITHIN THE 36 MONTHS(THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. SCOPE OF COMPL. THE INITIAL SCOPE OF THIS INVESTIGATION IS LIMITED TO A REVIEW OF COMPLAINTS WITH KNOWN BATCH NUMBERS RECEIVED WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL FOR THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED BECAUSE ANY PRODUCT ON THE MARKET WITHIN EXPIRY WOULD BE CAPTURED WITHIN THAT TIMEFRAME. A QUERY OF THE COMPLAINTS DATABASE FOR THE REPORTED PRODUCT, CLASS, AND SUB-LASS CAPTURED THE REQUIRED 5 DATA POINTS FOR THE REPORTED PRODUCT, CLASS, AND SUB-CLASS. OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. THE FINAL SCOPE WAS NOT EXPANDED AS A RESULT OF INVESTIGATION. DOCUMENT REVIEW SUMMARY: DEVIATIONS: A REVIEW OF DEVIATIONS, LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS COULD NOT BE PERFORMED FOR THE REPORTED COMPLAINT, AS THE BATCH IS UNKNOWN. MANUFACTURING/PACKAGING RECORDS: COMPLETE - ACCEPTABLE A REVIEW OF MANUFACTURING AND PACKAGING RECORDS COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, A REVIEW OF BATCH RECORDS FROM THE PREVIOUSLY INVESTIGATED COMPLAINTS DETERMINED TO BE IN SCOPE COULD NOT BE PERFORMED, AS THERE WERE NO COMPLAINTS WITH A KNOWN BATCH. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED THROUGH A FILTER WITH NITROGEN TO EXTRUDE THE LARGE, SOLID SPONGE BRICKS. THE BRICKS ARE DRIED, TRIMMED AND SPLIT. THE SPLIT BRICKS ARE THEN MILLED TO FORM POWDER. THE POWDER IS COLLECTED IN HIGH DENSITY POLYETHYLENE BAGS AND THEN SEALED INTO BULK CONTAINERS. THE GELFOAM POWDER IS THEN FILLED INTO INNER ENVELOPES USING A POWDER FILLING DEVICE. EACH ENVELOPE IS FILLED WITH A TARGET OF 1.2 GRAMS PER ENVELOPE AND A MINIMUM OF 1.0 GRAM PER ENVELOPE. TWO WEIGHT CHECKS OF EACH POWDER FILLING DEVICE ARE CONDUCTED AT 30-MINUTE INTERVALS TO ASSURE THAT THE DEVICE IS DISPENSING THE PROPER AMOUNT OF POWDER. THE FINAL PRODUCT YIELD IS CALCULATED AGAINST LIMITS FOR THE PRODUCT. THE INNER ENVELOPES ARE FOLDED OVER TWICE AND INSERTED INTO SLEEVES. THE FILLED SLEEVES ARE PLACED INTO TRAYS. THE SLEEVES (PEEL POUCHES) ARE SEALED, AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE ENVELOPES HAVE THE PROPER APPEARANCE, SEAL AND PRINT, AND ALL NOTED DEFECTIVE PRODUCT IS REMOVED FROM THE LOT PRIOR TO FINAL PACKAGING AND NO OPEN SIDE SEALS WERE OBSERVED. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. FOR GELFOAM SPONGE, THE BILL OF MATERIALS LISTS THE SPECIFIC PRODUCT COMPONENTS AND WEIGHTS REQUIRED FOR THE FORMULATION OF EACH BATCH. ALL MANUFACTURING MIXING SPEEDS, TIMES, AND TEMPERATURES HAVE SPECIFICATION CRITERIA. ALL EXTRUSION PARAMETERS HAVE REQUIRED SPECIFICATIONS. AFTER THE PRODUCT IS EXTRUDED INTO BRICKS, THE BRICKS ARE INSPECTED PRIOR TO BEING SLICED INTO INDIVIDUAL SPONGES. AFTER THE BRICKS ARE SLICED INTO SPONGES, A VISUAL INSPECTION IS PERFORMED FOR CONSISTENCY, UNIFORMITY, SHAPE, AND SIZE AT THE BEGINNING, MIDDLE, AND END OF SHIFTS AND EVERY FOUR HOURS IN BETWEEN. ALL DEFECTIVE SPONGES ARE IDENTIFIED AND REMOVED. THE GELFOAM IS PLACED INTO INNER ENVELOPES AND TRANSFERRED TO THE DOYEN PACKAGING EQUIPMENT TO PACKAGE THE ENVELOPES INTO PEEL POUCHES. THE DOYEN TAKES SIX ENVELOPES PER ROTATION BY SUCTION AND LOADS THEM ONTO A CONVEYER BELT AGAINST AN ALIGNMENT TAB. TWO OPERATORS SIT AT THE DOYEN TO CORRECT ALIGNMENT ISSUES PRIOR TO SEALING. THE FRONT AND BACK PAPERS, WHICH MAKE UP THE OUTER PEEL POUCH, ENCLOSE EACH INDIVIDUAL INNER ENVELOPE ENTIRELY WITH A FOUR-SIDED, HEAT-ACTIVATED ADHESIVE SEAL. THE TOP, BOTTOM, AND SIDES OF THE OUTER PEEL POUCHES ARE SEALED BY THREE DIFFERENT PARTS OF THE DOYEN WHICH EACH HAVE SEPARATE TEMPERATURE CONTROLS. EACH TEMPERATURE CONTROL IS VERIFIED AND DOCUMENTED IN THE BATCH RECORD. THE PEEL POUCHES ARE SEALED, AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE PEEL POUCHES HAVE THE PROPER APPEARANCE, SEAL AND PRINT. A SEAL INTEGRITY TEST (SIT) IS UTILIZED THROUGHOUT THE FINAL PACKAGING TO ENSURE THE SIDE SEALS OF THE PEEL POUCHES ARE ACCEPTABLE. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. AUDITS ARE PERFORMED ON THE FINISHED PACKAGED UNITS AT REGULAR INTERVALS THROUGHOUT THE FINAL PACKAGING PROCESS. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS, SUCH AS USE OF A SPECIFIC VALIDATED FORMULATION RECIPE AND AUTOMATIC RECORDING OF ALL WEIGHTS AND IDENTITIES OF RAW MATERIALS, DOCUMENTATION AND VERIFICATION OF CRITICAL FORMULATION, PROCESSING, AND STERILIZATION STEPS, AND FINAL RELEASE TESTING OF EACH BATCH TO ASSURE THAT IT MEETS ALL INTERNAL TARGETS AND REGISTERED SPECIFICATIONS ARE REVIEWED PRIOR TO RELEASE FOR DISTRIBUTION. THE EXISTING PROCESS CONTROLS ARE APPROPRIATE AND ACCEPTABLE; MEDICAL DEVICE QOP NOTIFICATION IS NOT REQUIRED. A REVIEW OF APRR FOR THE PRODUCTS AND TIMEFRAME IN SCOPE DID NOT FIND ANY ISSUE RELATING TO THE REPORTED COMPLAINT. QO BATCH HISTORY REPORT: A REVIEW OF RELEASE TESTING RESULTS COULD NOT BE PERFORMED AS THE REPORTED COMPLAINT BATCH IS UNKNOWN. RESERVE SAMPLE EVALUATION. RSRV. SAMPLE EVAL. RATIONALE: SEE VISUAL RESERVE SAMPLE EVALUATION DESCRIPTION BELOW. VISUAL RESRV SAMPLE EVAL DESC.: THE ANNUAL INSPECTION DATA FOR GELFOAM WAS REVIEWED FOR THE EXPIRY INTERVAL OF THE PRODUCT. THE DATA WAS REVIEWED IN COGNOS REPORTS FOR THE TIME PERIOD OF 09NOV2020-15NOV2023. ALL ANNUAL INSPECTION DATA WAS 'MEETS TEST' FOR THIS PRODUCT AND INTERVAL OF TIME REVIEWED. AN EXAMINATION OF RETAINED REFERENCE SAMPLES COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, THERE WERE NO PREVIOUSLY INVESTIGATED COMPLAINTS WITHIN SCOPE WITH A KNOWN BATCH NUMBER FOR WHICH AN EVALUATION OF PREVIOUS RETAINED REFERENCE SAMPLE EXAMINATIONS COULD BE REVIEWED. LOT TREND ASSMT. & RATIONALE: THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. LOT TREND ACTIONS TAKEN: THERE WERE NO LOT TRENDS IDENTIFIED; THEREFORE, NO LOT ACTIONS WERE REQUIRED AS A RESULT OF THIS INVESTIGATION. OTHER TREND ASSMT. & RATIONALE: MEDICAL DEVICE TREND ANALYSIS: THE COMPLAINT HISTORY FOR PRODUCTS WITH THE PRODUCT CATEGORY DEFINED AS ABSORBABLE MATERIAL', 'DELIVERY SYSTEM' AND 'TOPICAL' HAS BEEN REVIEWED. THE FOLLOWING PARAMETERS WERE USED: -PRODUCT CATEGORY: ABSORBABLE MATERIAL, DELIVERY SYSTEM, TOPICAL -TIME PERIOD: 15NOV2020 - 15NOV2023 -COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION AND ADVERSE EVENT -INVESTIGATING SITE: PFIZER KDP USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY RESPONSIBLE SITE NOTIFICATION AND BY THE CLASSIFICATIONS OF EXTERNAL CAUSE INVESTIGATION AND ADVERSE EVENT BASED ON SIMILAR COMPLAINT DESCRIPTIONS. THERE WAS ONE MONTH (APRIL 2023) THAT INCLUDED A HIGHER-THAN-NORMAL NUMBER OF COMPLAINTS (36 RESPECTIVELY); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF ADVERSE EVENT MD/MDCP,' AND THERE WAS ONE MONTH (APRIL 2023) THAT INCLUDED A HIGHER-THAN-NORMAL NUMBER OF COMPLAINTS (36); HOWEVER, THIS WAS DUE TO A PERIODIC LITERATURE REVIEW. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. MEDICAL DEVICE COMPONENT TREND: A REVIEW OF TRENDS FOR MEDICAL DEVICE CONSTITUENTS FOR THE REPORTED PRODUCT COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. COMPLAINT SAMPLE EVALUATION: SAMPLE-STATUS: SAMPLE AVAILABILITY UNKNOWN. SITE SAMPLE STATUS: NOT RECEIVED. RETURN SAMPLE EVALUATION: PFIZER SITE DID NOT RECEIVE A RETURNED SAMPLE. SAMPLE CONDITION. CONFIRMED COMPL SAMPLE DEFECT: N/A - NOT RECEIVED. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (07DEC2023): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON THE LIMITED INFORMATION PROVIDED AND THE KNOWN SAFETY PROFILE, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED ADVERSE EVENT (POST PROCEDURAL HEMORRHAGE) AND THE SUSPECT PRODUCT (GELFOAM) CANNOT BE CLEARLY ESTABLISHED AND CANNOT BE EXCLUDED. IT WAS NOTED THAT "ONE PATIENT DIED OF POSTOPERATIVE BLEEDING IN THE TUMOR CAVITY". THIS CASE WILL BE REASSESSED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1373779 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death| O |