BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY FENESTRATED LOW PRESSURE CUFFED

    MDR report key: 1940448 · Received December 20, 2010

    Report

    Report Number
    2936999-2010-01393
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 30, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK AND THEREFORE, THE DATE OF MANUFACTURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CALLER STATED THE TRACHEOSTOMY TUBES INNER CANNULA AND CAP FIT TOO LOOSELY AND THAT THE INNER CANNULA IS LOOSE ENOUGH THAT IT TWISTS OUT NIGHTLY. THE CAP USED ALSO FALLS OFF TOO EASILY. THE TRACH WAS IN USE FOR APPROX 3 WEEKS, AND WAS REPLACED WITH ANOTHER 8FEN. THE TUBE WAS DISCARDED AND THE LOT NUMBER IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention