BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AG 5PRCT SB 90MM

    MDR report key: 17869456 · Received October 4, 2023

    Report

    Report Number
    9680577-2023-00041
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 7, 2023
    Report Date
    October 16, 2023
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT HAS BEEN DETERMINED THAT MFR. REPORT # 9680577-2023-00041 HAS BEEN SUBMITTED IN ERROR. THE CONTAMINATION WAS NOTICED PRIOR TO USE AND WAS REPLACED. THIS DOES NOT MEET REQUIREMENTS OF A REPORTABLE EVENT. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.6. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON COMPLAINT (B)(4) AGAINST COLUMBIA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254071, LOT NUMBER 3171801 WITH RESPECT TO CONTAMINATION. EVENT DESCRIPTION: THE CUSTOMER REPORTED CONTAMINATED PLATES. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY WAS REVIEWED, AND SIMILAR COMPLAINTS WERE IDENTIFIED FOR THIS CATALOG NUMBER; HOWEVER, A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BHR WAS REVIEWED. NO DEVIATIONS FROM VALIDATED MANUFACTURING PROCESSES WERE IDENTIFIED. SAMPLE ANALYSIS: THE RETAIN SAMPLES WERE REVIEWED AND NO DEVIATION WAS DETECTED. RETURN SAMPLES WERE NOT PROVIDED; HOWEVER, PICTURE SAMPLE WAS SHARED SHOWING CONTAMINATED PLATES. 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 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 INTERNAL INVESTIGATION, THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLATE COLUMBIA AG 5PRCT SB 90MM WAS FOUND TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: COLUMBIA PLATES (B)(6), LOT 3171801: CONTAMINATION PRESENT IN ONE PACKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLATE COLUMBIA AG 5PRCT SB 90MM WAS FOUND TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: COLUMBIA PLATES ART 254071, LOT 3171801: CONTAMINATION PRESENT IN ONE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525815 PLATE COLUMBIA AG 5PRCT SB 90MM CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 3171801

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown