BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNCUFFED TRACHEAL TUBE

    MDR report key: 112279 · Received August 4, 1997

    Report

    Report Number
    MW1011862
    Event Type
    Malfunction
    Date Received
    August 4, 1997
    Date of Event
    July 14, 1997
    Report Date
    July 21, 1997
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ET TUBE HAD PLASTIC MEMBRANE ACROSS LUMEN JUST ABOVE DOUBLE BLACK LINE. MEMBRANE DID NOT ALLOW PASSAGE OF O2 INTO PT'S LUNGS. TUBE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNCUFFED TRACHEAL TUBE ET TUBE BTR MALLINCKRODT MEDICAL TPI, INC. * MP 39830

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Other