BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER PASSER 60CM

    MDR report key: 5406500 · Received January 19, 2016

    Report

    Report Number
    MW5059939
    Event Type
    Malfunction
    Date Received
    January 19, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 13, 2016
    Manufacturer
    MEDTRONIC
    Product Code
    GYK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    CATHETER PASSER, DISPOSABLE, 60CM WAS USED IN A VP SHUNT CASE. THE SAID ITEM USED WAS DEFECTIVE DUE TO EXCESS SPACING WHEN THE CATHETER WAS PLACED INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37591 CATHETER PASSER 60CM NA GYK MEDTRONIC 48409 D42237

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR