BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 22777749 · Received August 11, 2025

    Report

    Report Number
    1119779-2025-02935
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    August 2, 2025
    Report Date
    November 14, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT SHOULD BE CANCELED BECAUSE IT IS A DUPLICATE OF REPORT 3007420875-2025-00228.

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: NSU, OUY, PQA. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, A POSITIVE TRICHOMONAS VAGINALIS PATIENT RESULT WAS OBTAINED ON BD MAX¿ VAGINAL PANEL. TEST WAS REPEATED ON BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT USING BD CTGCTV2 FOR BD MAX¿ SYSTEM AND RESULT WAS TRICHOMONAS VAGINALIS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, A POSITIVE TRICHOMONAS VAGINALIS PATIENT RESULT WAS OBTAINED ON BD MAX¿ VAGINAL PANEL. TEST WAS REPEATED ON BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT USING BD CTGCTV2 FOR BD MAX¿ SYSTEM AND RESULT WAS TRICHOMONAS VAGINALIS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183811 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown