BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SCHAEDLER AGAR WITH VITAMIN K1 AND 5% SHEEP BLOOD, PLATE, 90 MM X 120

    MDR report key: 17402297 · Received July 26, 2023

    Report

    Report Number
    9680577-2023-00036
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    July 6, 2023
    Report Date
    July 24, 2023
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). H.6. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) AGAINST BD SCHAEDLER AGAR WITH VITAMIN K1 AND 5 % SHEEP BLOOD, CATALOG NUMBER 254084, LOT NUMBER 3122948 WITH RESPECT TO CONTAMINATION. EVENT DESCRIPTION: THE CUSTOMER REPORTED CONTAMINATION OF A PLATE. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED, AND NO SIMILAR COMPLAINT WAS REGISTERED FOR THIS LOT NUMBER. THUS, 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; HOWEVER, PICTURES SAMPLES WERE SHARED DEMONSTRATING A CONTAMINATION. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. THIS PRODUCT DOES NOT HAVE AN SAL (STERILITY ASSURANCE LEVEL) CLAIM. IT IS FILLED ASEPTICALLY; THEREFORE, AN OCCURRENCE OF A CONTAMINATION EVENT CANNOT BE ENTIRELY RULED OUT. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION AND THE PROVIDED PICTURES, THE COMPLAINT WAS CONFIRMED FOR CONTAMINATION. A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SCHAEDLER AGAR WITH VITAMIN K1 AND 5% SHEEP BLOOD, PLATE, 90 MM X 120, ONE PLATE WAS CONTAMINATED. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATED PLATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662584 BD SCHAEDLER AGAR WITH VITAMIN K1 AND 5% SHEEP BLOOD, PLATE, 90 MM X 120 CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON GMBH 3122948

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown