BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTIV PLUS

    MDR report key: 2083295 · Received May 3, 2011

    Report

    Report Number
    2083295
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 3, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSE ATTEMPTED TO REMOVE THE CATHETER. THE HUB OF THE CATHETER CAME OUT WITH ONLY A SMALL PIECE OF THE LINE ATTACHED. A TOURNIQUET WAS APPLIED, VASCULAR RADIOLOGY WAS CONSULTED, AND THEY REMOVED THE CATHETER BY CUTTING DOWN THE VEIN AT THE BEDSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTIV PLUS I.V.CATHETER FOZ SMITHS MEDICAL * ST1959045

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR