BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR FAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 1251003 · Received November 26, 2008

    Report

    Report Number
    1251003
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Date of Event
    November 19, 2008
    Report Date
    November 26, 2008
    Manufacturer
    HOLLISTER, INC.
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    A PIECE OF THE ENDOTRACHEAL TUBE HOLDER BROKE AND WAS FOUND IN THE ESOPHAGUS. THE PIECE WAS APPROXIMATELY < ½" WIDE AND < 1" LONG. IT WAS REMOVED WITHOUT INCIDENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR FAST ORAL ENDOTRACHEAL TUBE FASTENER DEVICE, FIXATION, TRACHEAL TUBE CBH HOLLISTER, INC. 9799 872148-107

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR