BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT
Report
- Report Number
- 1119779-2024-00596
- Event Type
- Malfunction
- Date Received
- August 13, 2024
- Date of Event
- July 10, 2024
- Report Date
- August 14, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- MDB
- UDI-DI
- 30382904421534
- PMA / PMN Number
- K920933
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D.4. MEDICAL DEVICE LOT #: 3249737. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-JUL-2024. H.4. DEVICE MANUFACTURE DATE: 06-SEP-2023. D.4. MEDICAL DEVICE LOT #: 4059819. D.4. MEDICAL DEVICE EXPIRATION DATE: 08-JAN-2025. H.4. DEVICE MANUFACTURE DATE: 28-FEB-2024. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: BACTEC FOS SUPPLEMENT IS MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXED INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED, DISPENSED INTO VIALS AND STOPPERED BY MACHINE. THE VIALS ARE LYOPHILIZED, AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). BACTEC FOS RECONSTITUTION FLUID IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND MIXED UNTIL A HOMOGENOUS SOLUTION IS OBTAINED. THE SOLUTION IS DISPENSED INTO VIALS AND CAPPED AND CRIMPED PER SOP. VIALS ARE AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE; PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, VIALS ARE LABELED AND PACKAGED IN A SEPARATE PACKING AREA. FOUR FOS SUPPLEMENT VIALS ARE THEN MANUALLY PACKAGED WITH ONE FOS RECONSTITUTION FLUID VIAL TO MAKE A BACTEC FOS SUPPLEMENT KIT (MATERIAL 442153). BACTEC FOS SUPPLEMENT KIT BATCH 3249737 IS COMPOSED OF FOS SUPPLEMENT BATCH 3214672 AND FOS RECONSTITUTION FLUID BATCH 3214676. BATCH HISTORY RECORD REVIEW FOR BACTEC FOS SUPPLEMENT KIT BATCH 3249737 WAS SATISFACTORY. NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. BATCH HISTORY RECORD REVIEWS FOR FOS SUPPLEMENT BATCH 3214672 AND FOS RECONSTITUTION FLUID BATCH 3214676 WERE SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. NO OTHER COMPLAINTS HAVE BEEN TAKEN EITHER BATCH. BACTEC FOS SUPPLEMENT KIT BATCH 4059819 IS COMPOSED OF FOS SUPPLEMENT BATCH 4040250 AND FOS RECONSTITUTION FLUID BATCH 4011793. BATCH HISTORY RECORD REVIEW FOR BACTEC FOS SUPPLEMENT KIT BATCH 4059819 WAS SATISFACTORY. NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. BATCH HISTORY RECORD REVIEWS FOR FOS SUPPLEMENT BATCH 4040250 AND FOS RECONSTITUTION FLUID BATCH 4011793 WERE SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. BATCH HISTORY RECORD REVIEW FOR BACTEC FOS SUPPLEMENT KIT BATCH 4059819 WAS SATISFACTORY. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. NO OTHER COMPLAINTS HAVE BEEN TAKEN EITHER BATCH. THERE WERE NO PHOTOS OR RETURNS SUBMITTED TO ASSIST WITH THIS INVESTIGATION. RETENTIONS OF BATCH 3214676 (RECONSTITUTION FLUID) WERE NOT AVAILABLE. RETENTIONS OF BATCH 3214672 (FOS SUPPLEMENT) WERE AVAILABLE AND USED FOR FURTHER INVESTIGATION. THERE WERE NO OBSERVED DEFECTS IN THE AVAILABLE RETENTIONS. TWO FOS SUPPLEMENT VIALS WERE RECONSTITUTED WITH STERILE WATER AND INCUBATED FOR 7 DAYS. ONE WAS PLACED INTO 20-25 DEGREE C INCUBATION, AND ONE WAS PLACED INTO 33-37 DEGREE C INCUBATION. THERE WAS NO GROWTH OBSERVED AFTER INCUBATION. THIS COMPLAINT FOR BACTEC FOS SUPPLEMENT KIT BATCH 3249737 CANNOT BE CONFIRMED. RETENTIONS OF BATCH 4011793 (RECONSTITUTION FLUID) AND RETENTIONS OF BATCH 4040250 (FOS SUPPLEMENT) WERE AVAILABLE AND USED FOR FURTHER INVESTIGATION. THERE WERE NO OBSERVED DEFECTS IN THE AVAILABLE RETENTIONS. TWO FOS SUPPLEMENT VIALS WERE RECONSTITUTED WITH TWO RECONSTITUTION FLUID VIALS AND INCUBATED FOR 7 DAYS. ONE WAS PLACED INTO 20-25 DEGREE C INCUBATION, AND ONE WAS PLACED INTO 33-37 DEGREE C INCUBATION. GROWTH WAS OBSERVED IN THE 33-37C SAMPLE AFTER INCUBATION. THE SAMPLE WAS SUBCULTURED ONTO TSA AND SDA PLATES AND SUBMITTED FOR ID. NO VIABLE GROWTH WAS RECOVERED. THIS COMPLAINT FOR BACTEC FOS SUPPLEMENT KIT BATCH 4059819 CAN BE CONFIRMED FOR CONTAMINATION. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND FOR DEFECTS.
THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 3249737. B5. IT WAS REPORTED WHILE USING BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT, THE CUSTOMER FOUND CONTAMINATION IN AN UNKNOWN QUANTITY OF MEDIA DURING QUALITY CONTROL TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR 11910483.
IT WAS REPORTED WHEN USING THE BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT, THE CUSTOMER FOUND CONTAMINATION IN MEDIA DURING QUALITY CONTROL TESTING. THE CONTAMINATION WAS TYPED AS BACILLUS USING MALDI-TOF TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO CONSEQUENCES REPORTED.
IT WAS REPORTED WHEN USING THE BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT, THE CUSTOMER FOUND CONTAMINATION IN MEDIA DURING QUALITY CONTROL TESTING. THE CONTAMINATION WAS TYPED AS BACILLUS USING MALDI-TOF TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO CONSEQUENCES REPORTED.
IT WAS REPORTED WHILE USING BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT, THE CUSTOMER FOUND CONTAMINATION IN AN UNKNOWN QUANTITY OF MEDIA DURING QUALITY CONTROL TESTING. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1164018 | BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON & CO. (SPARKS) | SEE H.11 | 30382904421534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |