BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD
Report
- Report Number
- 9680577-2022-00067
- Event Type
- Malfunction
- Date Received
- May 26, 2022
- Date of Event
- March 7, 2022
- Report Date
- July 8, 2022
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- JSJ
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INITIAL REPORTER PHONE#: (B)(6). INITIAL REPORTER FAX#: (B)(6). 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 B BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221353 WITH 510K NUMBER PREAMENDMENT. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY: EVENT DESCRIPTION: IT WAS REPORTED THAT 360 PLATES WOULD HAVE SHOW CONTAMINATION. COMPLAINT HISTORY REVIEW: THE COMPLAINT TRENDS WERE REVIEWED AND SIMILAR COMPLAINTS WERE FOUND FOR THIS LOT NUMBER. THEREFORE, A MRB (MATERIAL REVIEW BOARD) WAS PERFORMED AND THIS ISSUE WILL BE INVESTIGATED WITHIN A CAPA (CORRECTIVE AND PREVENTIVE ACTION). BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. SAMPLE ANALYSIS: PICTURES WERE PROVIDED SHOWING THE REPORTED CONTAMINATION. THE RETENTION SAMPLES WERE REVIEWED AND THE PLATES WERE FOUND TO BE WITHOUT DEVIATION. EVALUATION RESULTS AND INVESTIGATION CONCLUSION: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. PLEASE NOTE THAT THIS PRODUCT DOES NOT HAVE AN SAL CLAIM. IT IS FILLED ASEPTICALLY, THEREFORE AN OCCURRENCE OF A CONTAMINATION EVENT CANNOT BE ENTIRELY RULED OUT. WE ONLY RELEASE PRODUCT BATCHES TO THE MARKET WITH AN AQL (ACCEPTABLE QUALITY LEVEL) = 1.5. ALTHOUGH THIS CONTAMINATION LEVEL IS VERY LOW, WE CANNOT COMPLETELY EXCLUDE THAT A CUSTOMER MAY RECEIVE A CONTAMINATED PLATE. AS SEVERAL COMPLAINTS WERE REPORTED FOR THIS PRODUCT LOT NUMBER REGARDING CONTAMINATION, AN MRB AND CAPA WERE CREATED FOR FURTHER EVALUATION. THE ROOT CAUSE INVESTIGATION IS CURRENTLY ONGOING WITHIN THE MENTIONED CAPA. BASED UPON OUR INVESTIGATION THE COMPLAINT WAS CONFIRMED. WE WOULD SUGGEST THAT YOU SET ASIDE, AND NOT USE, ANY PREPARED PLATED MEDIA THAT DOES NOT MEET THE APPEARANCE 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). H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT WHILE USING BD (B)(4) CNA AGAR WITH 5% SHEEP BLOOD WERE CONTAMINATED. THIS EVENT OCCURRED 360 TIMES. THERE WAS NO REPORT OF PATIENT'S IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "360 CONTAMINATED PLATES."
IT WAS REPORTED THAT WHILE USING BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD WERE CONTAMINATED. THIS EVENT OCCURRED 360 TIMES. THERE WAS NO REPORT OF PATIENT'S IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "360 CONTAMINATED PLATES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2753243 | BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD | CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIA | JSJ | BECTON DICKINSON GMBH | 2033567 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |