BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR
Report
- Report Number
- 1119779-2023-00834
- Event Type
- Malfunction
- Date Received
- August 3, 2023
- Date of Event
- July 19, 2023
- Report Date
- August 14, 2025
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- UDI-DI
- 10382902217340
- PMA / PMN Number
- K803025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. 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 WERE CORRECTED AS THE LOT NUMBER PROVIDED BY THE CUSTOMER WAS INVALID: D4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . H.4. DEVICE MANUFACTURE DATE: UNKNOWN. THE BATCH NUMBER PROVIDED FOR THIS MALFUNCTION DID NOT MATCH THE MATERIAL, BUT A POTENTIAL BATCH NUMBER WAS IDENTIFIED AND THE INVESTIGATION WAS PERFORMED FOR THE POTENTIAL BATCH NUMBER. H.6. INVESTIGATION SUMMARY: THE BATCH NUMBER PROVIDED FOR INVESTIGATION WAS 3161027. MANUFACTURING RECORDS WERE REVIEWED AND THERE IS NO RECORD OF BATCH 3161027 MADE OF MATERIAL 221734. AN EXPIRATION DATE OF 2023-07-25 WAS PROVIDED. FROM REVIEW OF BATCHES OF MATERIAL 221734 IT APPEARS THAT SUBJECT BATCH FOR THIS INVESTIGATION IS 3101027. THE BATCH HISTORY RECORD FOR BATCH 3101027 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INVESTIGATION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL BIOBURDEN TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. AFFECTED PRODUCT DOES NOT HAVE ANY STERILITY CLAIMS; THE PRODUCT IS TESTED FOR BIOBURDEN PRIOR TO RELEASE TO ENSURE THAT IT CONFORMS TO PRODUCT SPECIFICATIONS. HOWEVER, THIS DOES NOT ENSURE THAT THE END-USER WILL NOT RECEIVE A CONTAMINATED PLATE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 3101027. RETENTION SAMPLES FROM BATCH 3101027 WERE NOT AVAILABLE FOR INSPECTION. ONE PHOTO WAS RECEIVED FOR INVESTIGATION. THE PHOTO SHOWS THE AGAR SURFACE OF EIGHT PLATES WITH GROWTH. NO PLATE PRINT OR PRODUCT LABELS ARE VISIBLE IN THE PHOTO FOR BATCH VERIFICATION. WITHOUT BATCH VERIFICATION, THE PHOTO CANNOT CONFIRM THE COMPLAINT. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR, A PLATE WAS CONTAMINATED. 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 THAT BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR CONTAMINATION OCCURRED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION OF MEDIA #221734.
IT WAS REPORTED THAT BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR CONTAMINATION OCCURRED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION OF MEDIA #221734
IT WAS REPORTED WHILE USING BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR, A PLATE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1467029 | BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON, DICKINSON & CO. (SPARKS) | UNKNOWN | 10382902217340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |