BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MUELLER HINTON II AGAR, PLATE, SQUARE, 120 MM X 20

    MDR report key: 22932283 · Received September 2, 2025

    Report

    Report Number
    9680577-2025-00366
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    April 26, 2024
    Report Date
    July 10, 2025
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JTZ
    UDI-DI
    30382902545188
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: (B)(6). INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON A COMPLAINT AGAINST MUELLER HINTON II AGAR, SQUARE, CATALOG NUMBER 254518, LOT NUMBER 4004714 WITH RESPECT TO PERFORMANCE. EVENT DESCRIPTION: THE CUSTOMER REPORTED VISIBLE ZONE WAS DETECTED ON BD MUELLER HINTON PLATE BY TRIMETHOPRIM AND SXT ANTIBIOTIC DISCS. HOWEVER, IT WAS NO GROWTH IN THE READING ZONE ON MUELLER-HINTON PLATE PRODUCED BY AXONLAB. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED FOR THE PAST 12 MONTHS, AND ONE SIMILAR COMPLAINT WAS REGISTERED FOR THIS CATALOG NUMBER. A TREND COULD NOT BE 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: RETAIN SAMPLES WERE ANALYZED FOR THE GROWTH PROMOTING ABILITY OF THE MEDIUM. ESCHERICHIA COLI ATCC 25922 AND ENTEROCOCCUS FAECALIS ATCC 29212 STRAINS WITH TRIMETHOPRIM-SULFAMETHOXAZOLE (SXT-1.25-23.75) USED FOR QUALITY RELEASE TESTING OF CATALOG NUMBER 254518 AND RECOMMENDED FOR USER QUALITY CONTROL OF THE MEDIUM WERE APPLIED TO MEDIUM OF LOT NO. 4004714. AFTER INCUBATION FOR 16-18 HOURS AT 35-37°C UNDER AEROBIC ATMOSPHERE, THE INHIBITED ZONES ARE WITHIN SPECIFICATION WITHOUT ANY DEVIATION. THERE WAS NO GROWTH IN THE READING ZONE. THE TESTING WAS PERFORMED ACCORDING TO EUCAST. RETURN SAMPLES WERE NOT PROVIDED; HOWEVER, A PICTURE SAMPLE WAS SHARED ILLUSTRATING A HAZE READING ZONE SXT ANTIBIOTIC DISC ON MUELLER HINTON II AGAR, SQUARE, CATALOG NUMBER 254518. ACCORDING TO THE PICTURE, THE CUSTOMER CARRIED OUT SUSCEPTIBILITY TESTING USING A COMBINATION OF 15 ANTIBIOTICS ON ONE PLATE. THERE WAS ANOTHER PLATE WITH E TEST FROM BIOMERIEUX WITH A CLEAR ZONE BY TRIMETHOPRIM AND SXT. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. NO DEVIATIONS COULD BE DETERMINED NEITHER DURING IN-PROCESS CONTROLS NOR DURING QC RELEASE OF THE CORRESPONDING BATCH NUMBER. WHEN EVALUATING THE IMAGE SAMPLE, IT CANNOT BE RULED OUT THAT INHIBITION WAS REDUCED DUE TO THE HIGH ANTIBIOTIC LOAD. INVESTIGATION CONCLUSION: BASED ON THE PROVIDED REPORT AND THE EVALUATION OF RETAIN SAMPLES, THIS COMPLAINT CANNOT BE CONFIRMED FOR A PERFORMANCE ISSUE. RESULTS OF GROWTH PROMOTION TESTS WERE SATISFACTORY. A CORRECTIVE AND PREVENTIVE ACTION WILL NOT BE IMPLEMENTED AS A TREND COULD NOT BE IDENTIFIED. FURTHER, THE RECLAIMED LOT IS ALREADY EXPIRED. 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 BD MUELLER HINTON II AGAR, PLATE, SQUARE, 120 MM X 20, THE ZONE OF INHIBITION WAS HAZY WHEN TESTED WITH TRIMETHOPRIM AND SXT ANTIBIOTIC DISCS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223137 BD MUELLER HINTON II AGAR, PLATE, SQUARE, 120 MM X 20 CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON DICKINSON GMBH 4004714 30382902545188

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown