BD BBL¿ COLUMBIA CNA AGAR W/5% SB// MACCONKEY II AGAR
Report
- Report Number
- 1119779-2024-00561
- Event Type
- Malfunction
- Date Received
- July 25, 2024
- Date of Event
- June 25, 2024
- Report Date
- August 14, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- JSJ
- UDI-DI
- 00382902216018
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221601, MEDIA IS FORMULATED AND SENT THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN. THE PETRI DISHES ARE SUBJECTED TO UV RADIATION TO DECREASE BIOBURDEN. THE PETRI DISHES ARE FILLED IN A POSITIVE PRESSURE HEPA FILTERED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED INTO SLEEVES TO DECREASE THE INTRODUCTION OF MICROBES. SLEEVES ARE THEN PACKAGED INTO CARTONS AND THEN TRANSFERRED TO A REFRIGERATED TRUCK (2 TO 8 DEGREES C) FOR SHIPMENT TO THE DISTRIBUTOR. BD DISTRIBUTORS ARE PROVIDED WITH THE STORAGE GUIDELINES FOR THE SHIPPING AND HANDLING OF BD MEDIA OF 2 TO 8 DEGREES C IN A DARK PLACE. THE BATCH HISTORY RECORD REVIEW FOR BATCH 4116876 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. ALL BATCHES ARE TESTED PRIOR TO RELEASE AND RESULTS REPORTED ON THE CERTIFICATE OF ANALYSIS WHICH CAN BE OBTAINED AT WWW.BD.COM/REGDOCS. COLUMBIA CAN//MACCONKEY II I PLATE IS STABILITY TESTED BIENNIALLY FOR BIOLOGICAL PERFORMANCE TO ENSURE SATISFACTORY PERFORMANCE THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS. ALL PERFORMANCE TESTING ON THIS BATCH WAS SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, THERE ARE NO OTHER COMPLAINTS TAKEN ON THIS BATCH 4116876 FOR THIS DEFECT. THERE WERE NO RETENTION SAMPLES AVAILABLE FOR INVESTIGATION OF THIS COMPLAINT. NO PHOTOS, NO RETURNS OR RETAINS WERE AVAILABLE FOR INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING BD BBL¿ COLUMBIA CNA AGAR W/5% SB// MACCONKEY II AGAR, THERE WERE AN UNKNOWN NUMBER OF PLATES WITH INSUFFICIENT GROWTH. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.
IT WAS REPORTED WHILE USING BD BBL¿ COLUMBIA CNA AGAR W/5% SB// MACCONKEY II AGAR 3 SAMPLES HAD INSUFFICIENT GROWTH OF GRAM NEGATIVE BACTERIA ON THE MACCONKEY SIDE OF THE PLATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHILE USING BD BBL¿ COLUMBIA CNA AGAR W/5% SB// MACCONKEY II AGAR 3 SAMPLES HAD INSUFFICIENT GROWTH OF GRAM NEGATIVE BACTERIA ON THE MACCONKEY SIDE OF THE PLATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHILE USING BD BBL¿ COLUMBIA CNA AGAR W/5% SB// MACCONKEY II AGAR, THERE WERE AN UNKNOWN NUMBER OF PLATES WITH INSUFFICIENT GROWTH. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 356397 | BD BBL¿ COLUMBIA CNA AGAR W/5% SB// MACCONKEY II AGAR | CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL | JSJ | BECTON DICKINSON & CO. (SPARKS) | 4116876 | 00382902216018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |