BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1191895 · Received October 7, 2008

    Report

    Report Number
    1191895
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 7, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US

    Narratives

    Description of Event or Problem · 1

    NURSE ATTACHED THE EXTENSION SET TO THE IV CATHETER, THEN LUER LOCKED A PRE-FILLED FLUSH SYRINGE TO THE NEEDLE-FREE VALVE ON THE EXTENSION SET. UPON TRYING TO INJECT THE FLUSH, THE VALVE WOULD NOT OPEN AND AN NEW EXTENSION SET WAS USED. FOUR EXTENSION SET FAILURES HAVE BEEN REPORTED AT THIS TIME, INCLUDING ONE WHERE THE THE VALVE POPPED OFF THE EXTENSION SET AND THE NURSE CAME IN THE ROOM WITH THE PATIENT BLEEDING OUT OF THE OPEN END OF THE EXTENSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TUBING, IV, EXTENSION SET FPA B. BRAUN MEDICAL, INC. 474921 00610008812

    Patients

    Seq Age Sex Outcome Treatment
    1 *