BEUDAMED
    FDA Adverse Event Other Summary report: N

    B/BRUN

    MDR report key: 602634 · Received May 12, 2005

    Report

    Report Number
    602634
    Event Type
    Other
    Date Received
    May 12, 2005
    Date of Event
    May 10, 2005
    Report Date
    May 11, 2005
    Manufacturer
    B/BRAUN, B. BRAUN MED INC.
    Product Code
    BSP
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STARTING SPINAL, ATTEMPTED TO PASS NEEDLE X2 BUT PT SENSITIVE AND MOVING AROUND. NEEDLE REMOVED AND LOCAL REINJECTED. INTRODUCER NEEDLE PLACED. UNSUCCESSFUL ATTEMPT. REMOVED SPINAL NEEDLE FROM INTRODUCER BUT ONLY THE STYLET RETURNED (NEEDLE REMAINED IN PT). COULD BARELY SEE NEEDLE IN INTRODUCER, NEEDLE SAFELY REMOVED WITH HEMOSTAT AND INTRODUCER REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B/BRUN S P ROTTE PENCIL POINT SPINAL NEEDLE BSP B/BRAUN, B. BRAUN MED INC. * 60247174

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other