BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENAX ENDOTRACHEAL TUBE

    MDR report key: 19239343 · Received May 2, 2024

    Report

    Report Number
    MW5154506
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Report Date
    April 29, 2024
    Manufacturer
    BRYAN MEDICAL INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE SURGEONS WERE TRYING TO INSTRUMENT THE AREA AROUND THE VOCAL CORDS IT WAS NOTED THAT TUBE KEPT COLLAPSING, WHICH RESULTED IN BRIEF EPISODES OF INCREASED AIRWAY PRESSURE. 6.5MM I.D X 10MM O.D (30FR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591670 TENAX ENDOTRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR BRYAN MEDICAL INC. TG0065-S 1502409D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown