BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 20978226 · Received December 19, 2024

    Report

    Report Number
    1119779-2024-01032
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    December 1, 2024
    Report Date
    January 24, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 UNABLE TO STAY OPEN, CUSTOMER WOULD HAVE TO HOLD IT OR ELSE IT WILL CLOSE BY ITSELF. SERVICE FOUND THE PINS HAVE SHEARED OFF IN THE DOOR ASSEMBLY FOR THE SPRING ARM. SERVICE REPLACED DOOR GAS SPRINGS AND HINGE; PERFORMED A FUNCTIONAL TEST SUCCESSFULLY; INSTRUMENT WAS TURNED BACK OVER TO THE CUSTOMER FOR NORMAL USE. THIS COMPLAINT IS A CONFIRMED FAILURE OF THE INSTRUMENT, AND THE ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT (B)(6) 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.

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY. 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 THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, THE DOOR WOULD NOT STAY OPEN. THERE WAS NO REPORT OF ANY INJURIES.

    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 ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951081 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown