BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD
Report
- Report Number
- 9680577-2022-00011
- Event Type
- Malfunction
- Date Received
- January 24, 2022
- Date of Event
- December 9, 2021
- Report Date
- March 17, 2022
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- KZI
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 1243759. EVENT DESCRIPTION: IT WAS REPORTED THAT PLATES WERE FOUND 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: A PICTURE SAMPLE WAS NOT PROVIDED. THE RETAIN SAMPLES WERE REVIEWED AND A DEVIATION WAS NOT DETECTED. 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. PLEASE BE AWARE THAT SUCH INVESTIGATION WILL TAKE ITS TIME. A DEFINITE ROOT CAUSE WAS NOT IDENTIFIED. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES. INVESTIGATION CONCLUSION: BASED ON THE INTERNAL INVESTIGATION, THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. SINCE A TREND WAS IDENTIFIED, A THOROUGH INVESTIGATION IS CURRENTLY UNDERWAY. 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).
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 221165 WHICH IS A PREAMENDMENT DEVICE.
IT WAS REPORTED THAT WHILE USING BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD BIOLOGICAL 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: "MEDIA WAS FOUND CONTAMINATED".
IT WAS REPORTED THAT WHILE USING BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD BIOLOGICAL 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: "MEDIA WAS FOUND CONTAMINATED"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1242730 | BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD | CULTURE MEDIA, ENRICHED | KZI | BECTON DICKINSON GMBH | 1243759 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |