BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 22320980 · Received June 24, 2025

    Report

    Report Number
    1119779-2025-00642
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 27, 2025
    Report Date
    July 29, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: NQX, NJR, OZN. E.1. INITIAL REPORTER PHONE NUMBER: (B)(6). G.4. THERE WERE MULTIPLE PMA/510K NUMBERS: K111860, K120138, K130470.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT (CATALOG NUMBER 441916 AND SERIAL NUMBER (B)(6)) HAD DOOR ISSUE. CUSTOMER REPORTED DOOR DOES NOT STAY OPEN INSTRUMENT DOOR CLOSES AUTOMATICALLY AFTER A WHILE. CUSTOMER DENIED FURTHER ASSISTANCE OR REPAIRS; INSTRUMENT WAS TURNED BACK OVER TO THE CUSTOMER FOR NORMAL USE. THIS COMPLAINT IS NOT A CONFIRMED FAILURE OF THE INSTRUMENT, AND THE ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. REVIEW OF DEVICE HISTORY RECORD FOR THIS INSTRUMENT IS NOT REQUIRED AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALL OF THE INSTRUMENT. SERVICE HISTORY REVIEW WAS PERFORMED, AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. NO SAMPLES WERE EXPECTED TO BE RECEIVED AS PART OF THIS COMPLAINT, AND THEREFORE NO SAMPLES WERE RETURNED, AND NO RETURNED MATERIAL INVESTIGATION COULD OCCUR. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THE FAILURE MODE DESCRIBED IN THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, THE DOOR WOULD NOT STAY OPEN. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, THE DOOR WOULD NOT STAY OPEN. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063940 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