BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B. BRAUN - SAFSITE

    MDR report key: 168424 · Received May 21, 1998

    Report

    Report Number
    MW1013850
    Event Type
    Malfunction
    Date Received
    May 21, 1998
    Date of Event
    May 8, 1998
    Report Date
    May 11, 1998
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN THE NURSES IN THE FACILITY WERE GOING TO ACCESS "Y" SITES W/ ACCESS PIN, THEY WOULD NOT SPIKE THE PORTS. NOTIFIED "TV" TECH, AND THEN REPORT SENT TO CRNI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B. BRAUN - SAFSITE ACCESS PIN FMI B. BRAUN MEDICAL, INC. AP - 2500 278260 APP. LOT.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other