BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AG 5PRCT SB 90MM

    MDR report key: 19910429 · Received August 5, 2024

    Report

    Report Number
    9680577-2024-00024
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 14, 2024
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    UDI-DI
    30382902540718
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY EVENT DESCRIPTION: THE CUSTOMER REPORTED CONTAMINATED PLATES WITH MAGGOTS. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY WAS REVIEWED FOR A PERIOD OF 12 MONTHS AND A TREND WAS NOT IDENTIFIED. 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: THE RETAIN SAMPLES WERE REVIEWED AND NO DEVIATION COULD BE DETECTED. RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER, HOWEVER, A VIDEO ILLUSTRATING THE CONTAMINATION WITH MAGGOTS WAS SHARED. EVALUATION RESULTS: BASED ON THE INVESTIGATION, NO DEVIATION COULD BE DETECTED IN OUR VALIDATED MANUFACTURING PROCESS. A DEVIATION COULD NEITHER BE DETECTED DURING THE REVIEW OF THE RETAIN SAMPLES NOR DURING THE REVIEW OF THE BATCH HISTORY RECORD. 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 CONTAMINATION 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 EVALUATION AND THE PROVIDED VIDEO, THE COMPLAINT WAS CONFIRMED FOR CONTAMINATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THIS ISSUE IS TREATED AS A SINGLE EVENT.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING PLATE COLUMBIA AG 5PRCT SB 90MM THAT MAGGOTS WERE INSIDE ONE (1) PLATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING PLATE COLUMBIA AG 5PRCT SB 90MM THAT MAGGOTS WERE INSIDE ONE (1) PLATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301219 PLATE COLUMBIA AG 5PRCT SB 90MM CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 4131276 30382902540718

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown