BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA AGAR PLATE WITH 5% SHEEP BLOOD

    MDR report key: 14104576 · Received April 13, 2022

    Report

    Report Number
    9680577-2022-00059
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 24, 2022
    Report Date
    June 22, 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

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: EVENT DESCRIPTION: THE CUSTOMER REPORTED THERE WAS GROWTH ON THE AGAR WHEN THE PLATES ARRIVED. COMPLAINT HISTORY REVIEW: THE COMPLAINT TRENDS WERE REVIEWED AND SIMILAR COMPLAINTS WERE FOUND FOR THIS CATALOG 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: RETAIN SAMPLES WERE REVIEWED AND NO DISCREPANCY WAS DETECTED RETURN SAMPLES WERE NOT PROVIDED AND THE SHARED PICTURE IS NOT ILLUSTRATING THE COMPLAINED ISSUE. EVALUATION RESULTS: 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. THE REVIEW OF THE BATCH HISTORY DID NO INDICATE ANY DISCREPANCY. INVESTIGATION CONCLUSION: ALTHOUGH NO PICTURE ILLUSTRATING THIS ISSUE WAS SHARED, THE COMPLAINT CAN BE CONFIRMED BASED ON THE TREND THE CAPA THAT WAS INITIATED. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINT FOR THIS ISSUE. H3 OTHER TEXT: OTHER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD BBL¿ COLUMBIA AGAR PLATES WITH 5% SHEEP BLOOD PLATES HAD CONTAMINATED AGAR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLATES ARRIVED CONTAMINATED. THERE WAS GROWTH ON THE AGAR WHEN THE PLATES ARRIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD BBL¿ COLUMBIA AGAR PLATES WITH 5% SHEEP BLOOD PLATES HAD CONTAMINATED AGAR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLATES ARRIVED CONTAMINATED. THERE WAS GROWTH ON THE AGAR WHEN THE PLATES ARRIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787772 BD BBL¿ COLUMBIA AGAR PLATE WITH 5% SHEEP BLOOD CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 2025984

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown