BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT SAFEGUARD

    MDR report key: 3121646 · Received May 17, 2013

    Report

    Report Number
    3121646
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 17, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    ENDOTRACHEAL TUBE HAD TO BE REPOSITIONED, ADVANCED BY ANESTHESIA WITH THE USE OF A GLIDESCOPE. PER NURSE, IT WAS NOTED TO BE "KINKED."WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ADVANCEMENT OF ENDOTRACHEAL TUBE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218948 MALLINCKRODT SAFEGUARD TUBE, TRACHEAL (W/WO CONNECTOR) BTR COVIDIEN SIZE 8.0 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR