BD TRUCOUNT TUBES
Report
- Report Number
- 2916837-2020-00092
- Event Type
- Malfunction
- Date Received
- August 24, 2020
- Date of Event
- August 3, 2020
- Report Date
- October 8, 2020
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- GKZ
- UDI-DI
- 00382903403349
- PMA / PMN Number
- K090967
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT ON PRODUCT 340334 BATCH 9310147 ON 04/AUG/2020. THE CLAIM ESTABLISHED THAT ¿WHEN OPEN THE PACKAGE, THE DESICCANT IS NORMAL, BUT THE PELLET WAS ABNORMAL SHRINKAGE AND ABOVE THE MESH¿. CUSTOMER PROVIDED PHOTO. MANUFACTURING DEFECT TREND: THERE ARE NO QUALITY NOTIFICATIONS (QNS) OR OUT-OF-SPECIFICATION (OOS) RELATED TO THE REPORTED ISSUE OR IDENTIFIED IN THE DEVICE HISTORY RECORD (DHR) DURING TUBES ASSEMBLING AND POUCHING PERIOD OF 04/OCT/2019 TO 30/OCT/2019. SUBASSEMBLY 91-0786 BATCH 19276 WAS MANUFACTURED ACCORDING TO REQUIREMENTS AND MET ASSEMBLING, POUCHING AND AQL ACCEPTANCE CRITERIA FOR RELEASE. THE ASSEMBLY PROCESS ALERT AND ACTION LIMITS ESTABLISHED (MF0184-PR-04) FOR THE 100% INSPECTION AND SORTING OF CRITICAL DEFECTS (INCLUDING PELLETS SHRINKAGE AND OVER RETAINER) WHERE NOT REACHED, HAVING AN ASSEMBLY PROCESS UNDER ESTABLISHED CONTROLS. NO DISCREPANCIES (OOS/QN) RELATED TO PELLET SHRINKAGE OR OVER RETAINER WERE INITIATED FOR SUBASSEMBLY 91-0786 LOT 19276 FROM COMPLAINT DATE 04/AUG/2019 TO 09/10/2020. RELATED QN(S): NONE COMPLAINT TREND: THERE ARE NONE ADDITIONAL COMPLAINTS CONFIRMED RELATED TO THE REPORTED CLAIM FOR PRODUCT 340334 BATCH 9310147 OR THE SUBASSEMBLY MATERIAL 91-0786 BATCH 19276 AS EVALUATED IN THE TRACKWISE SYSTEM FOR THE PERIOD OF 04/AUG/2019 TO 09/10/2020. THE MATERIAL 91-0786 BATCH 19276, WAS FURTHER USED IN 13 LOTS OF 8 DIFFERENT TRUCOUNT RELATED KITS, INCLUDING MATERIAL 340334 BATCH 9310147. THERE WERE NO COMPLAINTS ASSOCIATED TO ANY OF THESE 13 LOTS RELATED TO PELLET SHRINKAGE OR OVER THE RETAINER FOR THE PERIOD EVALUATED 04/AUG/2019 TO 09/10/2020. RELATED COMPLAINT(S): THIS COMPLAINT 91-0786 BATCH 19276, SHRUNK PELLET UNCONFIRMED TO BE RELATED TO MANUFACTURING PROCESS. THERE IS ANOTHER COMPLAINT, 91-0786 BATCH 20045, INVESTIGATED AND CLOSED AS SHRUNK PELLET UNCONFIRMED TO BE RELATED TO MANUFACTURING PROCESS. BATCH HISTORY RECORD (BHR) REVIEW: MATERIAL 340334 BATCH 9310147 WAS MADE AT SJ PLANT USING THE SUBASSEMBLY MATERIAL 91-0786 BATCH 19276 MADE AT CAYEY PLANT. BHR PART 91-0786 LOT 19276 WAS REVIEWED. THE MATERIAL MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THERE WERE (B)(4) (ASSEMBLED POUCHES) MADE, FROM THE PERIOD OF 04/OCT/2019 TO 30/OCT/2019, BEING 44 EMBOSSING IDS MANUFACTURED (PKG0003-PR POUCHED TUBE INSPECTION POINT RELEASE). THIS MANUFACTURING OUTPUT REPRESENTS (B)(4) ASSEMBLED TUBES. THE MATERIAL 91-0786 BATCH 19276, WAS FURTHER USED IN 13 LOTS OF 8 DIFFERENT TRUCOUNT RELATED KITS, INCLUDING MATERIAL 340334 BATCH 9310147. THE RAW MATERIAL USED IN THE SUBASSEMBLY PROCESS 91-0786, GOES THROUGH INCOMING QA INSPECTION. THE PELLET RAW MATERIAL 91-0195 BATCH 8355616 USED IN THIS ASSEMBLY PROCESS COMPLIED WITH THE INCOMING QA INSPECTION PROCESS. THE SUBASSEMBLY PROCESS HAS AUTOMATIC MACHINE ASSEMBLY, WHICH INCLUDES AUTOMATIC VISION SYSTEM FOR DETECTION AND SORTING OF CRITICAL DEFECTS. IN ADDITION, THE ASSEMBLED TUBES THAT PASS THE AUTOMATIC INSPECTION, GOES THROUGH 100% VISUAL INSPECTION AND SORTING FOR CRITICAL DEFECTS, WHICH ARE EVALUATED UNDER ALERT AND ACTION LIMITS SYSTEM ESTABLISHED. THE CRITICAL DEFECTS ARE RELATED TO PHYSICAL CHARACTERISTICS OF RETAINERS, PELLETS, TUBES, LABELS, CAPS AND SEALED POUCHES. THIS INSPECTION INCLUDES FOR PELLET SHRINKAGE AND PELLET OVER RETAINER EVALUATION. NONE OF THE ASSEMBLY MANUFACTURING DATES OF THE LOT 19276 SHOWED ALERT OR ACTION LIMITS (MF0183-PR-04 TRUCOUNT TOTAL CRITICAL DEFECTS DAILY PLOT) REACHED FOR CRITICAL DEFECTS AFTER THE 100% INSPECTION PROCESS. IN ADDITION, FOR EACH ASSEMBLY DAY, ALL AQLS PASSED ACCEPTANCE CRITERIA (C=0) FOR TUBE ASSEMBLY INSPECTION AS WELL AS POUCHED TUBE INSPECTION. THERE WERE NONE OUT OF SPECIFICATION (OOS) OR QUALITY NOTIFICATIONS (QNS) REPORTS RELATED TO THIS ASSEMBLY PROCESS. ROOM CONDITIONS WERE MONITORED AS PART OF THE PROCESS AND MET REQUIREMENTS THROUGHOUT THE MANUFACTURING PERIOD. CRITICAL DEFECTS ARE KNOWN AND RECOGNIZED IN THE ASSEMBLY PROCESS DOCUMENTATION (PKG0003-PR), FOR WHICH THERE ARE CONTROLS IN PLACE. THUS, THE ASSEMBLY PROCESS OCCURRED UNDER ESTABLISHED CONTROLS WITHOUT DISCREPANCIES OR DEVIATIONS AND IS CONSIDERED NOT TO BE RELATED TO THE CUSTOMER CLAIM. RETAIN SAMPLE EVALUATION / TESTING: RETAIN SAMPLE WAS NOT EVALUATED AS CUSTOMER PROVIDED PHOTO. EVALUATION OF THE PHOTO IS DISCUSSED IN THE RETURN SAMPLE EVALUATION SECTION BELOW. THE REPORTED CLAIM FOR SHRINKAGE PELLET OVER RETAINER IS A KNOWN DEFECT PER ASSEMBLY PROCESS PKG0003-PR AND FAILURE MODE EFFECT ANALYSIS FOR THE TRUCOUNT TUBE ASSEMBLY PROCESS (FMEA-TRUC-18030 REVISION 3). THE TUBE ASSEMBLY PROCESS DOCUMENTATION, POUCHING MANUFACTURING PROCESS AND ROOM CONDITIONS WERE REVIEWED AND MET REQUIREMENTS. CONTROL LIMITS ESTABLISHED IN THE ASSEMBLY PROCESS WERE ALL MET. REPORTED DEFECT RATE FOR BATCH 19276 IS CALCULATED AS 1.1DPPM (DEFECTIVE PARTS PER MILLION). THIS DEFECT RATE IS BELOW THE CRITICAL DEFECT OCCURRENCE (<10DPPM) ESTABLISHED FOR TUBE ASSEMBLY PROCESS. PER TDS 340334 (DOCUMENT NUMBER 23-3483-08 REVISION 11/2016) SECTION 6 PROCEDURE- STAINING STEP 1 NOTE, CUSTOMER IS INSTRUCTED AS FOLLOWS: ¿BEFORE USE, VERIFY THAT BD TRUCOUNT BEAD PELLET IS INTACT AND WITHIN THE METAL RETAINER AT THE BOTTOM OF THE TUBE. IF THIS IS NOT THE CASE, DISCARD THE BD TRUCOUNT TUBE AND REPLACE IT WITH ANOTHER¿. THUS, IT IS WELL ESTABLISHED IN THE IFU (INFORMATION FOR USER), THAT CUSTOMER SHOULD INSPECT THE TUBE PRIOR USAGE AND SHOULD NOT USE IT IF IT IS NOT INTACT. THE CUSTOMER SHOULD NOT USE THE TUBE IF A SHRINKAGE PELLET OVER THE RETAINER IS OBSERVED. PREVENTIONS RELATED TO USAGE IS ALREADY STATED IN THE IFU. IN ADDITION, THE LABEL OF THE FOIL POUCH OF MATERIAL 91-0786 (23-3823-08) ESTABLISHES CLEARLY THE STATEMENT RELATED TO STORAGE AS FOLLOWS: ¿USE TUBES WITHIN 1 MONTH AFTER OPENING THIS POUCH. CAREFULLY, RESEAL POUCH IMMEDIATELY AFTER EACH USE.¿ THE DEFECT OF PELLET SHRINKAGE COULD RESULT FROM EXPOSURE OF THE TUBE TO HUMIDITY WHEN IS TAKEN OUT OF THE SEALED POUCH. PER THE LABEL INFORMATION, ONCE THE POUCH IS OPENED, AND IF CAREFULLY RESEALED IMMEDIATELY, THE GUARANTEE FOR USAGE IS UP TO ONE MONTH. IN ADDITION, TDS 340334 ALSO REFER TO USING THE TUBE WITHIN 1 HOUR AFTER REMOVAL FROM THE FOIL POUCH. THUS, THERE IS ADVICE FOR THE CUSTOMER RELATED TO USAGE AND STORAGE TO AVOID AND REDUCE HUMIDITY EXPOSURE. ACCORDING TO SOP5011-18 (PRODUCT COMPLAINT INVESTIGATION), PER THE ESTABLISHED ALERT AND ACTION LIMITS AND ACCEPTANCE CRITERIA UNDER CONTROL, AS WELL AS THE IFU RELATED TO MATERIAL 340334, WHERE CLEARLY INDICATES THAT A TRUCOUNT TUBE THAT IS NOT INTACT SHOULD NOT BE USED, THE COMPLAINT IS CONSIDERED UNCONFIRMED. BDB CAYEY CONTINUES TO MONITOR RELATED CLAIMS ASSOCIATED TO 91-0786 BATCH 19276 TO IDENTIFY EMERGING TRENDS. RETURNED SAMPLE EVALUATION: FOR THIS COMPLAINT THE SAMPLE WAS NOT REQUESTED TO BE RETURNED BECAUSE CUSTOMER PHOTO WAS PROVIDED. THE CUSTOMER PHOTO WAS EVALUATED, SHOWING TWO TUBES, ONE WAS A CONTROL HAVING A NORMAL PELLET SIZE UNDER THE RETAINER, AND A SECOND TUBE SHOWING A SMALLER SIZE PELLET OVER THE RETAINER. THE SHRINKAGE OF PELLET SIZE AND TO BE OVER THE RETAINER IS RECOGNIZED AS A CRITICAL DEFECT IN THE ASSEMBLY PROCESS, FOR WHICH THERE IS IN PLACE AUTOMATIC MACHINE INSPECTION FOR DEFECT DETECTION AND SORTING, FOLLOWED BY A VISUAL 100% INSPECTION AND SORTING PROCESS FOR WHICH THERE IS ALERT AND ACTION LIMITS SYSTEM IN PLACE, AND FINALLY THERE IS AQL INSPECTION (C=0) FOR ASSEMBLED TUBES AND AQL INSPECTION (C=0) FOR POUCHED TUBES. FOR MATERIAL 91-0786 BATCH 19276 ALL THESE INSPECTIONS RESULTED UNDER CONTROL LIMITS ESTABLISHED. THUS, WHAT IS OBSERVED BY THE CUSTOMER IS NOT CONFIRMED TO BE RELATED TO THE MANUFACTURING PROCESS. EXPOSURE TO HUMIDITY IS A CAUSE FOR SHRUNK PELLETS, REASON WHY THERE IS IFU IN PLACE (TDS 340334 AND LABEL 23-3823-08) TO ADVICE THE FOLLOWING: TO CHECK THE DESICCANT TO BE IN CONDITION AND DISCARD TUBES IF NOT, TO INSPECT THE TUBE BEFORE USE FOR ASSURING THE PELLET IS UNDER RETAINER AND DISCARD IT IF NOT, AVOID EXPOSING THE TUBE FOR MORE THAN 1 HOUR AFTER REMOVAL FROM THE FOIL POUCH, TO USE THE TUBES IN AN OPEN POUCH WITHIN ONE MONTH. INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF COMPLAINT TREND, DEFECT TREND, BHR, ROOT CAUSE AND RISK ANALYSIS, THE REPORTED COMPLAINT WAS UNCONFIRMED AS RELATED TO ASSEMBLY PROCESS. ACCORDING TO SOP5011-18 (PRODUCT COMPLAINT INVESTIGATION), PER THE ESTABLISHED ALERT AND ACTION LIMITS AND ACCEPTANCE CRITERIA UNDER CONTROL, AS WELL AS THE IFU RELATED TO MATERIAL 340334, WHERE CLEARLY INDICATES THAT A TRUCOUNT TUBE THAT IS NOT INTACT SHOULD NOT BE USED, THE COMPLAINT IS CONSIDERED UNCONFIRMED. BDB CAYEY CONTINUES TO MONITOR RELATED CLAIMS ASSOCIATED TO 91-0786 BATCH 19276 TO IDENTIFY EMERGING TRENDS. RISK ANALYSIS: RISK ANALYSIS FOR REPORTED CLAIM WAS PERFORMED BY REVIEWING "FAILURE MODE AND EFFECT ANALYSIS (FMEA) FOR THE TRUCOUNT TUBE ASSEMBLY PROCESS" FMEA-TRUC-18030 REVISION 3. HAZARD(S) IDENTIFIED? X YES NO. HAZARD, INDICATES CAUSE OF ¿PELLET NOT UNDER RETAINER¿. SEVERITY: 7. PROBABILITY: 1. RISK INDEX: 7, MODERATE. IMPLEMENTATION: 1) CONTROLLED ROOM FOR RH (<10%; AHU 107). 2) SET UP OF STATION 3 DEFINED IN MF0183-PR AND MF0206-PR. 3) THERE IS ESTABLISHED PELLET INCOMING MATERIAL INSPECTION (91-0195RMS-PR). 4) AUTOMATIC MACHINE VISION SYSTEM DETECT SMALL PELLETS OVER RETAINER. 5) 100% VISUAL INSPECTION DETECT SMALL PELLETS OVER RETAINER. RISK CONTROL: 1) ACTION AND ALERT LIMITS MONITORED DAILY PER MF0183-PR-04 FOR 100% VISUAL INSPECTION DETECTION RESULTS. 2) QA0024-PR-04 DEFINES AQL INSPECTION PLAN. 3) IFU, TDS INDICATES TO DISCARD TUBE IF NOT INTACT. 4) IFU, TDS INDICATES TO USE TUBE WITHIN ONE HOUR AFTER REMOVAL FROM THE FOIL POUCH. 5) IFU, FOIL POUCH LABEL 23-3823-08 INDICATES TO USE TUBE WITHIN 1 MONTH AFTER OPENING OF THE POUCH. NEW HAZARD: NONE MITIGATION(S) ENOUGH: X YES NO. ROOT CAUSE ANALYSIS: THE ROOT CAUSE DETERMINATION TO THE DEFECT SHRINKAGE PELLET AND OVER RETAINER, IS NOT NECESSARY. THE DEFECT ON TRUCOUNT ASSEMBLY PROCESS 91-0786 IS RECOGNIZED BY THE TRUCOUNT PROCESS FMEA-TRUC-18030 REV 3. THE POSSIBLE ROOT CAUSES ANALYZED PER FMEA COULD BE RELATED TO ROOM RH OUT OF SPECIFIED CONDITIONS AND INCORRECT SET UP. THESE TWO CAUSES WERE NOT CONFIRMED IN THE MANUFACTURING PROCESS AS THE ROOM RELATIVE HUMIDITY CONDITION WAS UNDER CONTROL DURING ALL THE ASSEMBLY DAYS OF THE LOT 19276. ALSO, THE STATION 3 SET UP WAS COMPLETED ACCORDING TO PROCEDURES INSTRUCTIONS ESTABLISHED. THE ALERT AND ACTION LEVELS ESTABLISHED WERE NOT REACHED HAVING A NORMAL ASSEMBLY PROCESS WITHOUT DISCREPANCIES. EXPOSURE TO HUMIDITY IS A CAUSE FOR SHRINKAGE OF PELLETS, REASON WHY THERE ARE IFU INSTRUCTIONS TO AVOID TUBE EXPOSURE TO HUMIDITY. BASED ON THE LOW OCCURRENCE OF THE DEFECT, ITS RECOGNITION AS KNOWN AND POSSIBLE DEFECT, AND ITS CLASSIFICATION AS A CRITICAL DEFECT THAT SCRAP THE ASSEMBLED TUBE FOR WHICH IFU AND WARNINGS ARE IN PLACE, IT IS DETERMINED THAT NO FURTHER EVALUATION OF ROOT CAUSE IS DEEMED NECESSARY. CONCLUSION: BASED ON THE INVESTIGATION RESULT, COMPLAINT WAS UNCONFIRMED AS RELATED TO THE MANUFACTURING PROCESS. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT WHILE USING BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES THE RESULTS OF ABSOLUTE COUNTS ARE ABNORMAL. THERE WAS NO DELAY IN TREATMENT OR IMPACT TO PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN OPEN THE PACKAGE, THE DESICCANT IS NORMAL, BUT THE PELLET WAS ABNORMAL SHRINKAGE AND ABOVE THE MESH. DUE TO THIS ISSUE, THE RESULTS OF ABSOLUTE COUNTS ARE ABNORMAL. ADDITIONALLY, ON 2020-08-04 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES, ONLY A FEW MINUTES. (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.) 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO (GO TO QUESTION #3). 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO REDRAWN (GO TO QUESTION #4). 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED).
MEDICAL DEVICE LOT #: 19276 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED BY BD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE #: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: PMA / 510(K)# K980858, K971205, K971110, K970326, K970742, AND K071143. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).
IT WAS REPORTED THAT WHILE USING BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES THE RESULTS OF ABSOLUTE COUNTS ARE ABNORMAL. THERE WAS NO DELAY IN TREATMENT OR IMPACT TO PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN OPEN THE PACKAGE, THE DESICCANT IS NORMAL, BUT THE PELLET WAS ABNORMAL SHRINKAGE AND ABOVE THE MESH. DUE TO THIS ISSUE, THE RESULTS OF ABSOLUTE COUNTS ARE ABNORMAL. ADDITIONALLY, ON 2020-08-04 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES, ONLY A FEW MINUTES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. REDRAWN. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 910964 | BD TRUCOUNT TUBES | COUNTER, DIFFERENTIAL CELL | GKZ | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | 340334 | SEE H.10 | 00382903403349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |