BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 16372113 · Received February 13, 2023

    Report

    Report Number
    MW5114898
    Event Type
    Death
    Date Received
    February 13, 2023
    Date of Event
    January 30, 2023
    Report Date
    February 9, 2023
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER WAS BEING USED THIS PATIENT. THE STAFF NOTICE AIR LEAKAGE AND ASSESSED THE ETT(ENDOTRACHEAL TUBE) AND HOLLISTER. THE CHEEK PADS WERE FIRMLY IN PLACE AND BAND WAS STILL AROUND THE TUBE BUT THE ETT HAD SLIPPED OUT APPROX 8CM. TAN SECRETIONS WERE NOTED AROUND THE BAND AND THE ETT. THE PATIENT WAS REINTUBATED BUT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607553 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER DEVICE, FIXATION, TRACHEAL TUBE CBH HOLLISTER INCORPORATED 9799 2B092
    607554 ETT (ENDOTRACHEAL) TUBE TUBE, TRACHEAL (W/WO CONNECTOR) CBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Death