BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2032686 · Received March 21, 2011

    Report

    Report Number
    2032686
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 21, 2011
    Manufacturer
    COVIDIEN
    Product Code
    NIE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DIALYSIS CATHETER WAS PLACED BY THE PHYSICIAN. THE DIALYSIS RN REPORTED PIN HOLE LEAKS IN THE CATHETER WHILE IN DIALYSIS THREE AND A HALF HOURS LATER. A NEW TEMPORARY CATHETER WAS PLACED BY THE SAME PHYSICIAN. THE DIALYSIS WAS DELAYED DUE TO THE CATHETER EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MAHURKAR NIE COVIDIEN 8888102003 011223

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR DIALYSIS