BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-LO CUFFED ENDOTRACHEAL TUBE

    MDR report key: 1022949 · Received March 28, 2008

    Report

    Report Number
    2936999-2008-00142
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 5, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN HAS REQUESTED THE RETURN OF THE CUFFED HILO ENDOTRACHEAL TUBE FOR FAILURE INVESTGIATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE COMPLAINT INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IN 2008, COVIDIEN RECEIVED A COPY OF A USER FACILITY MEDWATCH REPORT WITH PT. THERE WAS NO OTHER REPORT NUMBER PROVIDED. THE REPORT STATES THE CUFF ON A 7.0 HI-LO ENDOTRACHEAL TUBE DEFLATED WHEN THE PT WAS TURNED. THE TUBE CAME OUT ABOUT 10CM AND THE PT WAS REINTUBATED. COVIDIEN CONTACTED THE RISK MANAGER AT THE FACILITY WHO FURTHER REPORTED, THERE WERE NO ABNORMAL ANATOMICAL PROBLEMS WITH THE PT AND THERE WAS NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-LO CUFFED ENDOTRACHEAL TUBE CUFFED ENDOTRACHEAL TUBE BTR COVIDIEN/FORMERLY TYCO HEALTHCARE HILO

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR