BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR FAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 1053101 · Received May 19, 2008

    Report

    Report Number
    1053101
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 19, 2008
    Manufacturer
    HOLLISTER INC.
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    ORAL ET FASTENER WAS IN PLACE ON PATIENT. WHILE PATIENT WAS BEING REPOSITIONED, ET FASTENER BROKE. THE TUBE HOLDER WAS FIRMLY ON THE ETT AND THE HOLDER WAS FIRMLY SECURED ON FACE, BUT THE WHITE PLASTIC CONNECTION BROKE OFF AND THE PATIENT BECAME EXTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR FAST ORAL ENDOTRACHEAL TUBE FASTENER HOLDER, ENDOTRACHEAL TUBE CBH HOLLISTER INC. 9799 *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR