BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (10CM)

    MDR report key: 3802385 · Received February 21, 2014

    Report

    Report Number
    3006260740-2014-00067
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Report Date
    January 29, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K121073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    INSERTER RN PLACED THE DEVICE, WITHOUT DIFFICULTY FREE HAND. CLEARLY SAW THE CATHETER IN THE VEIN ON ULTRASOUND. ADVANCED THE WIRE TILL THE CLICK WAS HEARD. ADVANCED ALL BUT BOUT THE LAST APPROX 2 CM OF THE CATHETER AS THE NURSE SAID SHE FELT RESISTANCE OR WHAT SHE THOUGHT WAS RESISTANCE. EXCELLENT FLOOD RETURN. WHEN WE PULLED THE RIGHT HAND BACK AND HELD HANDLES STILL, IT CAME BACK, WITH NORMAL EFFORT. WE TOOK OFF THE SILICONE PLUG, NO BLOOD RETURN. WE ATTACHED A SYRINGE AND PULLED BACK ON THE PLUNGER AND STARTED TO REMOVE THE CATHETER SLOWLY, HOPING TO GET BLOOD RETURN. BLOOD WITH ABOUT 5 CM EXTERNAL--LOTS OF BLOOD RETURN. THIS LINE WAS BEING USED TO ACCESS FOR A PICC. NURSE PLACED WIRE IN CATHETER, FELT RESISTANCE, WRITER FELT WHAT SHE FELT AS WRITER WAS STERILE AS WELL. ASKED HER TO REMOVE THE CATHETER. SHE DID. CATHETER CAME OUT WITHOUT ANY RESISTANCE. WHEN CATHETER REMOVED, SAW THE WIRE STICKING OUT THE SKIN, RN PULLED OUT THE WIRE. WE CHECKED THE GLIDE--MISSING ITS WIRE. WRITER MEASURED THE WIRE REMOVED AND THE LENGTH ON A NON USED GLIDE (TO ASSURE NO WIRE IN PATIENT) AND THEY WERE THE SAME, CONSIDERING A MM OF TWO INSIDE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110027 POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (10CM) FOZ C.R. BARD, INC. (BASD) REXL0405

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK.