BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE

    MDR report key: 23019172 · Received September 10, 2025

    Report

    Report Number
    MW5175896
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    September 4, 2025
    Report Date
    September 7, 2025
    Manufacturer
    TELEFLEX MEDICAL LLC
    Product Code
    BTO
    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

    DURING INTUBATION, THE CUFF FAILED TO INFLATE. THIS CUFF WAS ABLE TO BE INFLATED PRIOR TO INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2706860 ENDOTRACHEAL TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO TELEFLEX MEDICAL LLC 73C2500376

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Other