BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC XOMED

    MDR report key: 1210643 · Received October 23, 2008

    Report

    Report Number
    1210643
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 23, 2008
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING INTUBATION FOR ANESTHESIA, THE ET TUBE WAS NOTED TO HAVE A THIN WIRE PROTRUDING INTO THE INFLATABLE CUFF. THE ET TUBE WAS REMOVED FROM THE PATIENT AND REPLACED. A BRONCHOSCOPY WAS DONE FOLLOWING SURGERY TO ENSURE THAT PATIENT WAS NOT INJURED BY THE ET TUBE DEFECT. PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC XOMED ENDOTRACHEAL TUBE BTR MEDTRONIC XOMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR