BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RCI

    MDR report key: 21984623 · Received May 8, 2025

    Report

    Report Number
    21984623
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 24, 2025
    Report Date
    May 2, 2025
    Manufacturer
    TELEFLEX MEDICAL LLC
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EMERGENCY DEPARTMENT DOCTOR PLACED A 7.5 ETT [ENDOTRACHEAL TUBE] CUFFED, WHICH THE CUFF WAS PRIMED PRIOR TO INTUBATION, BUT ONCE PLACED IT WOULD NOT HOLD AIR IN THE PILOT BALLOON AS WELL AS CREATING A LARGE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120774 HUDSON RCI TUBE, TRACHEAL (W/WO CONNECTOR) BTR TELEFLEX MEDICAL LLC 73M2400385

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown