BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AG 5% SB 90MM 20

    MDR report key: 23064725 · Received September 16, 2025

    Report

    Report Number
    9680577-2025-02094
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    January 5, 2024
    Report Date
    June 13, 2025
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    UDI-DI
    30382902540053
    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

    E1. INITIAL REPORTER FACILITY NAME: (B)(6). H.6. INVESTIGATION SUMMARY: EVENT DESCRIPTION: THE CUSTOMER REPORTED CONTAMINATED PLATES AFTER OPENING THE PACKAGE AND DURING USE. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY WAS REVIEWED FOR A PERIOD OF 12 MONTHS, AND SIMILAR COMPLAINTS WERE IDENTIFIED FOR THIS CATALOG NUMBER; HOWEVER, A TREND WAS NOT IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCY WAS DETECTED. SAMPLE ANALYSIS: THE RETAIN SAMPLES WERE REVIEWED AND NO DEVIATION WAS DETECTED. RETURN SAMPLES WERE NOT PROVIDED, HOWEVER, PICTURES ILLUSTRATING THE CONTAMINATION WERE 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 ABOVE-MENTIONED EVALUATION AND THE SAMPLE PICTURES, THE COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PLATE COLUMBIA AG 5% SB 90MM 20 THAT THE MEDIA HAD BIOLOGICAL CONTAMINATION WHICH LED TO FALSE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2659452 PLATE COLUMBIA AG 5% SB 90MM 20 CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 3312039 30382902540053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown