BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL
Report
- Report Number
- 9680577-2022-00083
- 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.
H.6 INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON RECENT COMPLAINT (B)(4) AGAINST SABOURAUD AGAR WITH CHLORAMPHENICOL , CATALOG NUMBER 254091, LOT NUMBER 2101293. EVENT DESCRIPTION: THE CUSTOMER REPORTED THE LACK OF FUNGI GROWTH ON THESE PLATS WHICH INTENDED TO BE FOR FUNGI. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY WAS REVIEWED FOR A PERIOD OF 12 MONTHS. SIMILAR COMPLAINTS WERE RECORDED HOWEVER NO TREND WAS IDENTIFIED FOR THE COMPLAINED BATCH NUMBER. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEVIATION WAS DETECTED. ALL QC RELEASE TESTING WAS SATISFACTORY. SAMPLE ANALYSIS: RETAIN SAMPLES WERE NOT REVIEWED SINCE THE EXPIRY DATE WAS ALREADY EXCEEDED. HOWEVER THE COMPLAINT LIST HAS BEEN CHECKED AND NO FURTHER COMPLAINT RELATED TO THIS BATCH WAS RECORDED. ALSO THE DIFFERENT BATCHES OF THE INGREDIENTS THAT WERE USED FOR THIS PRODUCT WERE ANALYZED AND NO DEVIATION/NO QUALITY NOTIFICATION WAS REPORTED. NEITHER RETURN SAMPLES, NOR PICTURE SAMPLES WERE PROVIDED. EVALUATION SUMMARY AND INVESTIGATION CONCLUSION: BASED ON THE ABOVE MENTIONED EVALUATION A DEVIATION OF OUR VALIDATED MANUFACTURING PROCESS COULD BE EXCLUDED. NO DISCREPANCY WAS DETECTED NEITHER DURING THE QUALITY CONTROL LAB TEST NOR DURING THE BATCH HISTORY REVIEWED. FURTHERMORE NO QUALITY NOTIFICATION RELATED TO THE PRODUCT AND THE INGREDIENTS WAS INITIATED AND NO FURTHER COMPLAINT RELATED TO THIS BATCH NUMBER WAS RECORDED. CONSIDERING THE EVALUATION ABOVE NO DEVIATION WAS DETECTED IN OUR PROCESS; THEREFORE THE COMPLAINT CANNOT BE CONFIRMED. HOWEVER BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES.
IT WAS REPORTED THAT WHILE USING BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL THAT THERE WAS INSUFFICIENT GROWTH. THIS IS A REPORT OF A 120 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 WHILE USING BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL THAT THERE WAS INSUFFICIENT GROWTH. THIS IS A REPORT OF A 120 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 |
|---|---|---|---|---|---|---|---|
| 1668187 | BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL | CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL | JSI | BECTON DICKINSON GMBH | 2101293 | 00382902540915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |