BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHERIDAN ETT

    MDR report key: 23149146 · Received September 25, 2025

    Report

    Report Number
    MW5176625
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    September 12, 2025
    Report Date
    September 22, 2025
    Manufacturer
    TELEFLEX MEDICAL LLC
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LEAK NOTED IN THE ETT CUFF. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302931 SHERIDAN ETT TUBE, TRACHEAL (W/WO CONNECTOR) BTR TELEFLEX MEDICAL LLC 5-10114

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other