BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERGLIDE

    MDR report key: 3904297 · Received June 26, 2014

    Report

    Report Number
    3904297
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    March 18, 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

    PLACING MIDLINE IN PRE-OP HOLDING SPOT. UNABLE TO SLIDE CATHETER OVER GUIDE WIRE AFTER BLOOD RETURN. WENT TO PULL NEEDLE BACK AND UNABLE. PULLED WHOLE CATHETER AND NEEDLE OUT BECAUSE WOULDN'T PULL OUT SMOOTHLY. AT LAST APPROX INCH OF CATHETER COULD FEEL CATHETER STUCK UNDER SKIN JUST BELOW SURFACE. SHOWED THE PHYSICIAN THE PROBLEM. COULD FEEL END OF CATHETER STILL ATTACHED (NOT DEEP. WITH THE PHYSICIAN'S ADVISEMENT AT MY SIDE, I PULLED WITH STEADY PRESSURE. I WAS ABLE TO REMOVE INTACT CATHETER AND IT DIDN'T TAKE MUCH PRESSURE. THERE WAS A SMALL AMOUNT OF BLEEDING AT THE SITE. POST INCIDENT, SITE APPLIED WITH DRESSING. CATHETER LOOKS TWISTED, MAKING A KINK IN CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374075 POWERGLIDE CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM FOZ BARD ACCESS SYSTEMS, INC. * REXL0406

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR