BD BBL¿ MIDDLEBROOK OADC ENRICHMENT
Report
- Report Number
- 1119779-2021-02164
- Event Type
- Malfunction
- Date Received
- January 14, 2022
- Date of Event
- December 24, 2021
- Report Date
- March 30, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSK
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: MATERIAL 212351 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED, AND THE SOLUTION IS THEN STERILE FILTERED. BOTTLES ARE FILLED AND CAPS ARE APPLIED AND TORQUED MECHANICALLY PER STANDARD OPERATING PROCEDURE (SOP). BOTTLES ARE THEN SENT TO A SEPARATE PACKAGING AREA FOR LABELING AND TO BE PACKED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD REVIEW FOR BATCH 1204341 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION AND FILTERING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WAS SATISFACTORY AT TIME OF RELEASE. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE MEDIA APPEARANCE. NO FOREIGN OBJECTS WERE OBSERVED IN QC SAMPLES AT THE TIME OF RELEASE. IF FOREIGN MATTER HAD BEEN NOTED DURING QC TESTING, THE PRODUCT WOULD HAVE BEEN PLACED ON QUALITY NOTIFICATION AND FURTHER ANALYSIS INCLUDING 100% INSPECTION OF THE BATCH WOULD HAVE BEEN CONDUCTED. THE COMPLAINT HISTORY WAS REVIEWED, AND THREE OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR CONTAMINATION. NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR FOREIGN MATERIAL. ONE RETENTION BOTTLE FROM BATCH 1204341 WAS AVAILABLE FOR INSPECTION. NO EVIDENCE OF TURBIDITY/CONTAMINATION WAS OBSERVED IN THE RETENTION SAMPLE FROM VISUAL INSPECTION. NO FOREIGN MATERIAL SUCH AS BLACK PARTICLES WAS OBSERVED IN THE RETENTION SAMPLE. FOR FURTHER INVESTIGATION THE RETENTION BOTTLE WAS INCUBATED AT 33-37 DEGREES CELSIUS FOR A SEVEN-DAY INCUBATION PERIOD. AT THE END OF THE INCUBATION PERIOD NO MICROBIAL GROWTH OR TURBIDITY OF THE MEDIA WAS OBSERVED. NO FOREIGN MATERIAL WAS OBSERVED AFTER INCUBATION. THREE PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS ONE BOTTLE THE CAP CANNOT BE OBSERVED FROM THE PHOTO. THE BOTTLE IS FROM BATCH 1204341. THERE IS A LARGE WHITE MASS POSSIBLY FUNGAL BUT NO WAY TO DETERMINE FROM VISUAL INSPECTION. THE SECOND PHOTO SHOWS A PARTIAL BOTTLE. THE CAP IN THIS PHOTO CANNOT BE SEEN. THERE DOES APPEAR TO BE A TINY BLACK PARTICLE TOWARDS THE BOTTOM OF THE BOTTLE. THE LAST PHOTO SHOWS A PARTIAL BOTTLE. THE BOTTLE APPEARS TO BE TURNED ON THE SIDE. THERE DOES APPEAR TO BE A TINY BLACK PARTICLE. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FROM THE EVIDENCE PROVIDED IN THE PHOTOS AS THESE PHOTOS WERE PREVIOUSLY ASSOCIATED WITH ANOTHER COMPLAINT FROM THIS CUSTOMER.
IT HAS BEEN REPORTED THAT THE BD BBL¿ MIDDLEBROOK OADC ENRICHMENT HAS BEEN FOUND EXPERIENCING FOUR OCCURRENCES OF CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: SMALL BLACK INSOLUBLE PARTICLES WERE FOUND IN 3 VIALS. CLUMPY INSOLUBLE SUBSTANCE WAS FOUND IN ONE VIAL.
IT HAS BEEN REPORTED THAT THE BD BBL¿ MIDDLEBROOK OADC ENRICHMENT HAS BEEN FOUND EXPERIENCING FOUR OCCURRENCES OF CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: SMALL BLACK INSOLUBLE PARTICLES WERE FOUND IN 3 VIALS. CLUMPY INSOLUBLE SUBSTANCE WAS FOUND IN ONE VIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 729545 | BD BBL¿ MIDDLEBROOK OADC ENRICHMENT | SUPPLEMENT, CULTURE MEDIA | JSK | BECTON, DICKINSON & CO. (SPARKS) | 1204341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |