BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY SCT SPECIALIZED TRACHEOSTOMY TUBE

    MDR report key: 1612458 · Received February 19, 2010

    Report

    Report Number
    2936999-2010-00139
    Event Type
    Injury
    Date Received
    February 19, 2010
    Date of Event
    January 20, 2010
    Report Date
    January 20, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGES PILOT BALLOON LINE HAS LEAK. THE TUBE FAILED AFTER 14 DAYS OF USE. IT WOULD NOT HOLD AIR. CUSTOMER STATES THAT THE LEAK IS IN THE PILOT LINE AT THE POINT WHERE IT ENTERS THE OUTER CANNULA. PATIENT WAS RECANNULATED WITH A NEW TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SCT SPECIALIZED TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 0909001967

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention