BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTIV PLUS SAFETY IV CATHETER RADIOPAQUE

    MDR report key: 3212792 · Received July 2, 2013

    Report

    Report Number
    MW5030792
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 30, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SMITH MEDICAL ASD, INC
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE HOSPITALIST PHYSICIAN: THE PT WAS APPARENTLY MANIPULATING HER IV LAST NIGHT. A PORTION OF IT BROKE OFF AND REMAINED IN HER PERIPHERAL VEIN IN THE WRIST. THE PT HERSELF FISHED THIS OUT AND GAVE THIS PIECE TO THE NURSE AND THIS DID APPEAR TO REPRESENT THE WHOLE IV. ACCORDING TO THE NURSE, THE PT ROLLED OVER ON THE IV AND IT BEGAN TO HURT AND WAS RED. NO MENTION OF THE PT MANIPULATING IT BY MESSING WITH IT, BUT WHEN SHE ROLLED ON IT. BECAUSE THE IV WAS HURTING, THE PT ASKED FOR IT TO BE RESTARTED. WHEN THE NURSE REMOVED THE IV, THE DISTAL END WAS MISSING. THE PT DID FISH THE PIECE OUT AND IT WAS GIVEN TO THE NURSE AND EXAMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300328 PROTECTIV PLUS SAFETY IV CATHETER RADIOPAQUE JELCO 20G X 1 1/4" FOZ SMITH MEDICAL ASD, INC ST2480297

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR