BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MUELLER HINTON II AGAR

    MDR report key: 17221015 · Received June 28, 2023

    Report

    Report Number
    9680577-2023-00031
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 13, 2023
    Report Date
    June 27, 2023
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JTZ
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(6) AGAINST MUELLER HINTON II AGAR, CATALOG NUMBER 254081, LOT NUMBER 3082823 WITH RESPECT TO CONTAMINATION. EVENT DESCRIPTION: THE CUSTOMER REPORTED 30 FROM 120 MH II AGAR PLATES ARRIVED WITH BIOLOGICAL CONTAMINATION. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED, AND ONE SIMILAR COMPLAINT WAS REGISTERED FOR THIS LOT NUMBER; HOWEVER, NO TREND WAS 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 SHOWING CONTAMINATED PLATES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE OF BD BBL¿ MUELLER HINTON II AGAR, THIRTY PLATES ARRIVED CONTAMINATED. THERE WAS NO PATIENT IMPACT NOR RESULTS REPORTED TO CLINICIANS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "30 FROM 120 PLATES ARRIVED WITH BIOLOGICAL COLONIES ALREADY GROWING ON THE PLATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783225 BD BBL¿ MUELLER HINTON II AGAR CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON DICKINSON GMBH 3082823

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown