BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AG 5% SB 90MM 20

    MDR report key: 14739439 · Received June 17, 2022

    Report

    Report Number
    9680577-2022-00073
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    June 7, 2022
    Report Date
    July 5, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). 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

    EVENT DESCRIPTION: THE CUSTOMER REPORTED THE PLATES ARE CONTAMINATED (FRESHLY OPENED PACKAGE) COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY HAS BEEN REVIEWED AND SIMILAR ISSUES WERE REGISTERED FOR THIS CATALOG NUMBER; HOWEVER NO TREND WAS IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BHR WAS REVIEWED. NO DEVIATIONS FROM VALIDATED MANUFACTURING PROCESSES WERE IDENTIFIED. SAMPLE ANALYSIS: RETAIN SAMPLES COULDN'T BE REVIEWED HAS THE COMPLAINED BATCH WAS ALREADY EXPIRED WHEN ISSUING THE COMPLAINT. RETURN SAMPLES WERE NOT PROVIDED BUT PICTURES SHOWING BLACK SPOTS ON THE PLATES WERE SHARED. 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 THE COMPLAINT WAS ISSUED AFTER THE EXPIRATION DATE OF THE PRODUCT, NO FURTHER ACTIONS WILL BE INITIATED. INVESTIGATION CONCLUSION: BASED ON THE ABOVE MENTIONED INVESTIGATIONS, THE COMPLAINT CANNOT BE CONFIRMED. HOWEVER BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING THE PLATE COLUMBIA AG 5% SB 90MM 20 CONTAMINATION WAS IDENTIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORT: "THE PLATES ARE CONTAMINATED (FRESHLY OPENED PACKAGE)".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING THE PLATE COLUMBIA AG 5% SB 90MM 20 CONTAMINATION WAS IDENTIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "THE PLATES ARE CONTAMINATED (FRESHLY OPENED PACKAGE)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224523 PLATE COLUMBIA AG 5% SB 90MM 20 CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 2060090

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown