PLATE COLUMBIA AG 5PRCT SB 90MM
Report
- Report Number
- 9680577-2022-00069
- Event Type
- Malfunction
- Date Received
- June 1, 2022
- Date of Event
- May 3, 2022
- Report Date
- June 7, 2022
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- KZI
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- 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. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221263 WHICH IS A PREAMENDMENT DEVICE.
H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT AGAINST COLUMBIA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254071, LOT NUMBER 2063343. EVENT DESCRIPTION: THE CUSTOMER REPORTED PLATES TO BE CONTAMINATED. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY WAS REVIEWED AND A TREND WAS IDENTIFIED FOR THIS PRODUCT. BATCH HISTORY RECORD (BHR) REVIEW: THE BHR WAS REVIEWED. NO DEVIATIONS FROM VALIDATED MANUFACTURING PROCESSES WERE IDENTIFIED. SAMPLE ANALYSIS: THE RETAIN SAMPLES WERE REVIEWED AND NO DEVIATION WAS DETECTED PICTURE SAMPLE WAS PROVIDED SHOWING CONTAMINATED PLATES. EVALUATION RESULTS: THIS PRODUCT IS FILLED UNDER ASEPTIC CONDITIONS. THEREFORE STERILITY OF THE FINISHED PRODUCT CANNOT BE GUARANTEED. UNFORTUNATELY A 100 % INSPECTION LEVEL FOR STERILITY IS NOT POSSIBLE AND STERILITY TESTING IS CARRIED OUT ON THE BASIS OF A REPRESENTATIVE SAMPLE. IN CONSEQUENCE, OCCASIONAL CONTAMINATIONS CANNOT BE PREVENTED. IN THIS CASE, A TREND WAS IDENTIFIED. CURRENTLY SEVERAL CROSS-FUNCTIONAL TEAMS ARE CONDUCTING EXTENSIVE INVESTIGATION TO REDUCE THE OCCURRENCE FOR SUCH SUBLIMINAL CONTAMINATIONS. A DEFINITE ROOT CAUSE WAS NOT IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON THE INTERNAL INVESTIGATION, THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. SINCE A TREND WAS IDENTIFIED, FURTHER INVESTIGATION IS CURRENTLY BEING PERFORMED. WE REGRET THE INCONVENIENCES AND 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 600 PLATE COLUMBIA AG 5PRCT SB 90MM BIOLOGICAL CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A CEPHEID TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: "CONTAMINATED PLATES".
IT WAS REPORTED THAT WHILE USING 600 PLATE COLUMBIA AG 5PRCT SB 90MM BIOLOGICAL CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A CEPHEID TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: "CONTAMINATED PLATES".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306396 | PLATE COLUMBIA AG 5PRCT SB 90MM | CULTURE MEDIA, ENRICHED | KZI | BECTON DICKINSON GMBH | 2063343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |