BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE, 5.0

    MDR report key: 12650 · Received April 8, 1994

    Report

    Report Number
    MW1001523
    Event Type
    Malfunction
    Date Received
    April 8, 1994
    Date of Event
    March 30, 1994
    Report Date
    April 7, 1994
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ANESTHESIOLOGIST COULD NOT VENTILATE THE PT THROUGH THE ENDOTRACHEAL TUBE. THE TUBE WAS REMOVED AND REINSERTED BUT IT REMAINED OCCLUDED. THE PT WAS NOT ADVERSELY AFFECTED. THIS REPORT WAS PROMPTED BY AN FDA PUBLIC HEALTH ADVISORY: OCCLUDED ENDOTRACHEAL TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE, 5.0 BTR MALLINCKRODT MEDICAL TPI, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 *