BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ PLATE COLUMBIA III AGAR 5% SB 90MM

    MDR report key: 16943758 · Received May 16, 2023

    Report

    Report Number
    9680577-2023-00023
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    May 2, 2023
    Report Date
    May 25, 2023
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 7842363 AGAINST COLUMBIA III AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254098, LOT NUMBER 3082615 WITH RESPECT TO CONTAMINATION. EVENT DESCRIPTION: IT WAS REPORTED THAT RELATIVELY MANY CONTAMINATED COLUMBIA III PLATES IN THE 120 CARTONS. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. SIMILAR COMPLAINTS WERE REPORTED DURING THAT PERIOD OF TIME ON THIS PRODUCT. HOWEVER, A TREND COULD NOT BE DETECTED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. RETURNED SAMPLE ANALYSIS: PHYSICAL SAMPLES WERE NOT RETURNED FOR EVALUATION. PICTURES WERE PROVIDED. BASED ON THE EVALUATION OF THE SHARED PICTURES CONTAMINATION COULD BE DETECTED. RETAIN SAMPLES WERE REVIEWED AND INCUBATED FOR 7 DAYS AT 28°C. NO CONTAMINATION COULD BE IDENTIFIED. EVALUATION SUMMARY: 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 (STERILITY ASSURANCE LEVEL) CLAIM. IT IS FILLED ASEPTICALLY; THEREFORE, AN OCCURRENCE OF A CONTAMINATION EVENT CANNOT BE ENTIRELY RULED OUT. INVESTIGATION CONCLUSION: BASED ON THE ABOVE-MENTIONED EVALUATION THE COMPLAINT CAN BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. BD REGRETS THE INCONVENIENCES YOU HAVE EXPERIENCED AND WILL CONTINUE TO MONITOR SIMILAR INCOMING COMPLAINTS. SEE H.10.

    Additional Manufacturer Narrative · 0

    H.3. 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 APPROXIMATELY 26 CARTONS BD BBL¿ PLATE COLUMBIA III AGAR 5% SB 90MM WITH CONTAMINATION CONTAMINATION - UNFORTUNATELY, AT THE MOMENT WE FIND RELATIVELY MANY CONTAMINATED COLUMBIA III PLATES IN THE 120 CARTONS. IT IS THE BATCH 308615 (2023-06-14). THERE ARE ABOUT 2-3 PACKS PER CARTON AND WE HAVE ORDERED 26 CARTONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 26 CARTONS BD BBL¿ PLATE COLUMBIA III AGAR 5% SB 90MM WITH CONTAMINATION CONTAMINATION - UNFORTUNATELY, AT THE MOMENT WE FIND RELATIVELY MANY CONTAMINATED COLUMBIA III PLATES IN THE 120 CARTONS. IT IS THE BATCH 308615 (2023-06-14). THERE ARE ABOUT 2-3 PACKS PER CARTON AND WE HAVE ORDERED 26 CARTONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774088 BD BBL¿ PLATE COLUMBIA III AGAR 5% SB 90MM CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 3082615

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown