BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ

    MDR report key: 3251166 · Received July 19, 2013

    Report

    Report Number
    3251166
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 9, 2013
    Report Date
    July 19, 2013
    Manufacturer
    COOK MEDICAL INCORPORATED
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING A CHEST TUBE THE STIFF WIRE GUIDE KINKED AND HAD TO BE REPLACED. THE PATIENT WAS NOT HARMED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CHEST TUBE PLACEMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338297 AMPLATZ WIRE, GUIDE, CATHETER DQX COOK MEDICAL INCORPORATED * 3391078

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR