BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿)
Report
- Report Number
- 9680577-2022-00080
- Event Type
- Malfunction
- Date Received
- July 15, 2022
- Date of Event
- June 16, 2022
- Report Date
- August 5, 2022
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- JSO
- PMA / PMN Number
- K945569
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT CATALOG NUMBER 221240 WITH 510K # K945569. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT 5401881 AGAINST CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿), CATALOG NUMBER 254060, LOT NUMBER 2101333 COMPLAINT HISTORY WAS REVIEWED FOR A PERIOD OF 12 MONTHS. SIMILAR COMPLAINT WAS REGISTERED HOWEVER NO TREND WAS IDENTIFIED 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 RETURN SAMPLES WERE NOT PROVIDED HOWEVER PICTURE SAMPLE WAS SHARED 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. SINCE A TREND WAS NOT IDENTIFIED A SYSTEMATIC DEVIATION IN OUR VALIDATED MANUFACTURING PROCESS CAN BE EXCLUDED. HOWEVER A CROSS-FUNCTIONAL TEAM IS 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. BD REGRETS THE INCONVENIENCES YOU HAVE BEEN EXPERIENCING AND WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES 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¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿) ENRICHMENT THE CUSTOMER NOTICED THE PRESENCE OF VISIBLE FILAMENTOUS FUNGI ON EACH PLATE. THIS EVENT OCCURRED 12 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DUE TO THE PRESENCE OF VISIBLE FILAMENTOUS FUNGI ON EACH PLATE. [THEY] SENT A PHOTO OF THE INQUIRED MATERIAL WHICH I ATTACH. "
IT WAS REPORTED THAT WHILE USING BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿) ENRICHMENT THE CUSTOMER NOTICED THE PRESENCE OF VISIBLE FILAMENTOUS FUNGI ON EACH PLATE. THIS EVENT OCCURRED 12 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DUE TO THE PRESENCE OF VISIBLE FILAMENTOUS FUNGI ON EACH PLATE. [THEY] SENT A PHOTO OF THE INQUIRED MATERIAL WHICH I ATTACH "
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1025690 | BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿) | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON | JSO | BECTON DICKINSON GMBH | 2101333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |