BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR FAST

    MDR report key: 1220926 · Received November 4, 2008

    Report

    Report Number
    MW5008885
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 4, 2008
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT'S ENDOTRACHEAL TUBE WAS SECURED BY THE ORAL ENDOTRACHEAL FASTENER, ANCHOR FAST. UPON REPOSITIONING THE PT, THE PLASTIC FASTENER BROKE OFF FROM THE BASE AND THE ENDOTRACHEAL TUBE CAME OUT OF THE PT WITH THE PLASTIC PIECE ATTACHED. THE REMAINING PORTION STAYED SECURED TO THE PT'S FACE. THE PT WAS RE-INTUBATED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR FAST ORAL ENDOTRACHEAL TUBE FASTENER CBH HOLLISTER INCORPORATED 9799

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening VENTILATOR: PURTIAN BENNETT| RUSCH ENDOTRACHEAL TUBE SIZE 7.5