BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHERIDAN/CF ENDOTRACHEAL TUBE

    MDR report key: 23464992 · Received November 4, 2025

    Report

    Report Number
    MW5178472
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 23, 2025
    Report Date
    October 30, 2025
    Manufacturer
    TELEFLEX MEDICAL LLC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT'S ET TUBE SIZE 8 HAD A CUFF LEAK. THIS LEAK WAS ATTEMPTED TO BE FIXED BY A CUFF LEAK REPAIR KIT. THIS DIDN'T HELP SO THE ET TUBE WAS EXCHANGED VIA BOUGIE. THE REPLACEMENT SIZE 8.0 ETT CUFF WOULDN'T HOLD AIR, SO IT THEN HAD TO ALSO BE EXCHANGED WITH ANOTHER SIZE 8.0 ETT VIA BOUGIE. IT APPEARS THERE IS A SLIGHT SEPARATION WHERE THE CUFF MEETS THE TUBE. PT CODE: 4582. DEVICE CODES: 2946, 1562. REF REPORT: MW5178473.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607658 SHERIDAN/CF ENDOTRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR TELEFLEX MEDICAL LLC. 73G2400443

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Life Threatening