BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEFLEX MEDICAL ENDOTRACHAEL TUBE 8.0MM

    MDR report key: 1481623 · Received September 17, 2009

    Report

    Report Number
    MW5012813
    Event Type
    Malfunction
    Date Received
    September 17, 2009
    Report Date
    September 17, 2009
    Manufacturer
    HUDSON RCI
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT REQUIRED INTUBATION. THE ENDOTRACHEAL TUBE WAS CHECKED PRIOR TO USE WITH 10CC AIR AND BALLOON HELD WITHOUT ANY PROBLEMS. AFTER PT WAS INTUBATED, THE TUBE WOULD NOT HOLD AIR AND HAD TO BE EXCHANGED. TOTAL OF 3 LIKE PRODUCTS WERE DISCOVERED TO NOT HOLD AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEFLEX MEDICAL ENDOTRACHAEL TUBE 8.0MM ETT BTR HUDSON RCI * 01K0800496

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR