BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL
Report
- Report Number
- 9680577-2022-00082
- Event Type
- Malfunction
- Date Received
- July 26, 2022
- Date of Event
- June 30, 2022
- Report Date
- September 18, 2022
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- JSI
- UDI-DI
- 00382902540915
- PMA / PMN Number
- SEE H.10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PMA/510K#: EXEMPT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON RECENT COMPLAINT (B)(4) AGAINST SABOURAUD AGAR WITH CHLORAMPHENICOL, CATALOG NUMBER 254091, LOT NUMBER 2087985. EVENT DESCRIPTION: THE CUSTOMER DID NOT GOT ANY FUNGI GROWTH ON THESE PLATS WHICH INTENDED TO BE FOR FUNGI. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY HAS BEEN REVIEWED AND FOR THIS PRODUCT, SEVERAL COMPLAINTS WERE REPORTED FOR A PERFORMANCE ISSUE. THEREFORE, A TREND WAS IDENTIFIED, AND FURTHER INVESTIGATION WAS PERFORMED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY HAS BEEN REVIEWED. IT WAS IDENTIFIED THAT THE CHLORAMPHENICOL CONTAINING IN THIS PRODUCT WAS PROBABLY AFFECTED AND FURTHER FINISHED PRODUCTS WERE IDENTIFIED. SAMPLE ANALYSIS: A PERFORMANCE TEST HAS BEEN CONDUCTED ON THE RETAIN SAMPLES AND NO DEVIATION WAS DETECTED. HOWEVER WHILE TESTING OTHER BATCHES CONTAINING CHLORAMPHENICOL, THE PERFORMANCE ISSUE COULD BE CONFIRMED. A PICTURE SAMPLE DOCUMENTING THE REPORTED ISSUE WAS NOT PROVIDED. EVALUATION RESULTS AND INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMATIC FAILURE IN OUR MANUFACTURING PROCESS. ALL THE RELEASE TESTING WAS SATISFACTORY AND ALSO THE RETEST PERFORMED ON THE RETAIN SAMPLES DID NOT REVEAL ANY DEVIATION TO THE REQUIREMENT. HOWEVER WHILE TESTING OTHER BATCHES CONTAINING CHLORAMPHENICOL, THE PERFORMANCE ISSUE COULD BE CONFIRMED. BD HAS IDENTIFIED AN OUTSIDE SUPPLIER ISSUE WITH THIS PLATE¿S IMPREGNATED ANTIBIOTIC, CHLORAMPHENICOL, WHICH RESULTS IN A REDUCTION IN THE ANTIBACTERIAL ACTIVITY OF THE CHLORAMPHENICOL OVER THE SHELF LIFE OF THE AGAR. AS A RESULT A PRODUCT RECALL HAS BEEN INITIATED FOR THE AFFECTED LOTS IN THE AFFECTED REGIONS. BASED ON THE ABOVE MENTIONED EVALUATION, THIS COMPLAINT WAS CONFIRMED. BD WILL CONTINUE MONITORING INCOMING COMPLAINT WITH SIMILAR FAILURE MODE.
IT WAS REPORTED THAT DURING USE OF BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL THERE WAS INSUFFICIENT GROWTH. THIS IS A SINGLE REPORT OF 60 OCCURRENCES. NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER DID NOT GOT ANY FUNGI GROWTH ON THESE PLATS WHICH INTENDED TO BE FOR FUNGI. FOR COMPARISON THEY PLATED ASPERGILLUS AND DIFFERENT CANDIDA SPECIES ON TSA BA, COLUMBIA CNA AND ON SABOURAUD AGAR OF THESE LOT # AND FOUND NO GROWTH OF ANY FUNGAL ONLY IN THE SABOURAUD AGAR.
IT WAS REPORTED THAT DURING USE OF BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL THERE WAS INSUFFICIENT GROWTH. THIS IS A SINGLE REPORT OF 60 OCCURRENCES. NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER DID NOT GOT ANY FUNGI GROWTH ON THESE PLATS WHICH INTENDED TO BE FOR FUNGI. FOR COMPARISON THEY PLATED ASPERGILLUS AND DIFFERENT CANDIDA SPECIES ON TSA BA, COLUMBIA CNA AND ON SABOURAUD AGAR OF THESE LOT # AND FOUND NO GROWTH OF ANY FUNGAL ONLY IN THE SABOURAUD AGAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1342021 | BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL | CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL | JSI | BECTON DICKINSON GMBH | 2087985 | 00382902540915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |