BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AG 5PRCT SB 90MM

    MDR report key: 16450566 · Received February 28, 2023

    Report

    Report Number
    9680577-2023-00007
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    February 14, 2023
    Report Date
    March 6, 2023
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY. THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT 7213392 AGAINST COLUMBIA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254071, LOT NUMBER 3017439. EVENT DESCRIPTION: THE CUSTOMER REPORTED 39 PLATES OF 120 WERE CONTAMINATED WITH BACTERIA. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY WAS REVIEWED, AND NO SIMILAR COMPLAINT WAS IDENTIFIED FOR THIS BATCH NUMBER. 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 BASED ON A REPRESENTATIVE SAMPLE. IN CONSEQUENCE, OCCASIONAL CONTAMINATIONS CANNOT BE PREVENTED BY 100%; ALTHOUGH THE CONTAMINATION RATE REMAINS BELOW THE ACCEPTANCE LEVEL. 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 EXPERIENCED AND WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES. WE WOULD SUGGEST THAT YOU 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).

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLATE COLUMBIA AG 5PRCT SB 90MM 39 PLATES WERE CONTAMINATED WITH BACTERIA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 39 PLATES OF 120 WERE CONTAMINATED WITH BACTERIA (CFR PHOTOS UNDER RELATED).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLATE COLUMBIA AG 5PRCT SB 90MM 39 PLATES WERE CONTAMINATED WITH BACTERIA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 39 PLATES OF 120 WERE CONTAMINATED WITH BACTERIA (CFR PHOTOS UNDER RELATED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799942 PLATE COLUMBIA AG 5PRCT SB 90MM CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 3017439

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown