BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERGLIDE

    MDR report key: 3904370 · Received June 26, 2014

    Report

    Report Number
    3904370
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    January 17, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING MIDLINE IN PATIENT FOR VASCULAR ACCESS. USING ULTRASOUND, I WAS ABLE TO ACCESS THE VEIN AND CONFIRMED THIS BY BLOOD RETURN IN THE CATHETER. I THEN ADVANCED THE WIRE ON THE POWERGLIDE CATHETER WITHOUT ANY COMPLICATIONS. I THEN LOWERED MY ANGLE AND BEGAN TO ADVANCE THE CATHETER AND WAS ABLE TO ADVANCE IT UNTIL ONLY 1 CM WAS OUTSIDE THE PATIENT. I BEGAN TO PULL THE NEEDLE OUT IN SMOOTH STEADY MOTION AND FELT RESISTANCE. I WAS UNABLE TO RETRACT THE NEEDLE. YOU CANNOT RE-ADVANCE THE NEEDLE SO INSTEAD I DECIDED TO PULL THE ENTIRE DEVICE AS A WHOLE OUT OF THE PATIENT AND START OVER WITH NEW CATHETER. THE POWERGLIDE WAS REMOVED WITH CATHETER APPEARING MANGLED BUT INTACT. PATIENT DENIED PAIN OR DISCOMFORT TO ARM AND NO SWELLING OR HARDNESS WAS NOTED. NEW MIDLINE WAS PLACED IN PATIENT'S ARM WITHOUT ANY DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374457 POWERGLIDE CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM FOZ BARD ACCESS SYSTEMS, INC. * REXL0401

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR