BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MARTIN-LEWIS AGAR

    MDR report key: 22922354 · Received August 29, 2025

    Report

    Report Number
    9680577-2025-00340
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    February 20, 2024
    Report Date
    July 8, 2025
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JTY
    UDI-DI
    30382902540299
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT NORMALLY PROTEUS SPP ARE INHIBITED FOR GROWTH ON THIS MEDIUM DUE TO THE ANTIBIOTICS THAT ARE INCLUDED INTO THE MEDIUM CFR PACKAGE INSERT. WITH THIS LOT THE OVERGROWTH OF PROTEUS SPP IS NOTICED. THE COMPLAINT HISTORY WAS REVIEWED, AND NO SIMILAR COMPLAINTS WERE REPORTED FOR THE AFFECTED CATALOG NUMBER. A TREND WAS NOT IDENTIFIED. THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. RETAIN SAMPLES WERE ANALYZED IN A PERFORMANCE TEST USING PROTEUS MIRABILIS ATCC 43071, PROTEUS MIRABILIS ATCC 14153 AND PROTEUS MIRABILIS ATCC 12453. NO DEVIATION WAS DETECTED, AND GROWTH WAS STILL INHIBITED AFTER 48 HOURS AT 35-37°C IN CO2 ATMOSPHERE INCUBATION. NO RETURN SAMPLES WERE PROVIDED BY THE CUSTOMER FOR ANALYSIS. A PICTURE WAS SHARED SHOWING A PLATE WITH GROWTH OF BACTERIA. BASED UPON OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMATIC FAILURE IN OUR MANUFACTURING PROCESS. ALL THE RELEASE TESTING WAS SATISFACTORY AND ADDITIONALLY, THE RETEST PERFORMED ON THE RETAIN SAMPLES WITH PROTEUS MIRABILIS ATCC 43071, PROTEUS MIRABILIS ATCC 14153 AND PROTEUS MIRABILIS ATCC 12453 WAS SATISFACTORY. SINCE NO TREND WAS IDENTIFIED AND NO PROCESS DEVIATION COULD BE DETECTED, FURTHER ACTIONS ARE NOT INDICATED AT THIS POINT. BASED ON THE RESULTS OF THE INVESTIGATION AND THE EVALUATION OF RETAIN SAMPLES WE CANNOT CONFIRM THIS COMPLAINT. HOWEVER, BD WILL CONTINUE MONITORING INCOMING COMPLAINT WITH SIMILAR FAILURE MODE. 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 BBL¿ MARTIN-LEWIS AGAR, THE MEDIA FAILED TO INHIBIT GROWTH OF PROTEUS SPECIES. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2880255 BD BBL¿ MARTIN-LEWIS AGAR CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA JTY BECTON DICKINSON GMBH 3332386 30382902540299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown