PLATE SABOURAUD AGAR W/CHMP 90MM 20
Report
- Report Number
- 9680577-2021-00073
- Event Type
- Malfunction
- Date Received
- November 7, 2021
- Date of Event
- October 5, 2021
- Report Date
- December 10, 2021
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- 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.
H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT AGAINST BDTM SABOURAUD AGAR WITH CHLORAMPHENICOL, CATALOG NUMBER 254091, LOT NUMBER 1223096 WITH RESPECT TO CONTAMINATION. EVENT DESCRIPTION: BEFORE UNPACKING A MEDIA PLATE WAS FOUND WITH GROWING BLACK MICROBIAL CONTAMINATION. COMPLAINT HISTORY REVIEW: THE COMPLAINT TREND WAS REVIEWED FOR A PERIOD COVERING 12 MONTHS. THREE SIMILAR COMPLAINTS WERE REGISTERED FOR LOT 1223096. A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH RECORD FOR THE RESPECTIVE LOT WAS REVIEWED. NO DEVIATIONS FROM THE VALIDATED PROCESSES WERE REGISTERED. IN ADDITION, THE PRODUCT PASSED QC RELEASE TESTING WITHOUT ANY DEVIATIONS. SAMPLE ANALYSIS: RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. PICTURE SAMPLES, PROVIDED BY THE CUSTOMER, SHOW A STACK OF 10 PLATES WRAPPED INSIDE THE PRIMARY PACKAGING WITH ONE PLATE BEING CONTAMINATED BY A BLACK MICROORGANISM. EVALUATION RESULTS: BASED ON THE INTERNAL INVESTIGATION AND THE PICTURE SAMPLES PROVIDED, THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. NEITHER A TREND NOR A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED. INVESTIGATION CONCLUSION: ASEPTIC MANUFACTURING PROCESSES ARE UNABLE TO GUARANTEE STERILITY OF THE GIVEN PRODUCT. SINCE A 100 % INSPECTION IS NOT POSSIBLE FOR ASEPTIC PRODUCTS, STERILITY TESTING CARRIED OUT ON THE BASIS OF A REPRESENTATIVE SAMPLE. THEREFORE, OCCASIONAL CONTAMINATION CANNOT BE PREVENTED. NEVERTHELESS, TO IMPROVE CUSTOMER EXPERIENCE, AN INTERDISCIPLINARY TEAM WAS FOUNDED TO FURTHER REDUCE THE OCCURRENCE OF THESE SUBLIMINAL CONTAMINATIONS. EFFECTIVENESS CHECKS INDICATE A SIGNIFICANT IMPROVEMENT TO THE SITUATION CAUSED BY THE TRIGGERED ACTIONS. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES. WE WOULD SUGGEST TO SET ASIDE, AND NOT USE, ANY PREPARED PLATED MEDIA THAT DOES NOT MEET THE APPEARANCE AND PERFORMANCE SPECIFICATION AS IT IS DESCRIBED ON THE BD CERTIFICATE OF ANALYSIS. THIS IS CONSISTENT WITH INDUSTRY RECOMMENDATIONS FOR INSPECTION OF CULTURE MEDIA PRIOR TO USE (E.G. ¿GOOD PRACTICES FOR PHARMACEUTICAL MICROBIOLOGY LABORATORIES¿, WHO TECHNICAL REPORT SERIES, NO. 961, 2011, ANNEX 2; CHAPTER <1117> ¿MICROBIOLOGY BEST LABORATORY PRACTICES¿ THE UNITED STATES PHARMACOPEIA; AND THE DIFCO & BBL MANUAL).
IT WAS REPORTED THAT WHILE USING BD PLATE SABOURAUD AGAR W/CHMP 90MM 20 CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLIENT HAVE RECEIVED A BAG WITH 10 PLATES AND 1 OF THEM IS CONTAMINATED. BAG IS CLOSED , NO PLATE HAS BEEN USED.
IT WAS REPORTED THAT WHILE USING BD PLATE SABOURAUD AGAR W/CHMP 90MM 20 CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLIENT HAVE RECEIVED A BAG WITH 10 PLATES AND 1 OF THEM IS CONTAMINATED. BAG IS CLOSED , NO PLATE HAS BEEN USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1654284 | PLATE SABOURAUD AGAR W/CHMP 90MM 20 | NA | JSI | BECTON, DICKINSON & CO. (SPARKS) | 1223096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |