BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 2810372 · Received October 31, 2012

    Report

    Report Number
    1119193-2012-00008
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 31, 2012
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IN USE FOR 8 DAYS PRIOR TO THE SHUTTLE CLAMP SEPARATING FROM THE TRACK. THERE WAS NO BREAKAGE OBSERVED ON THE CLAMP ITSELF. IT IS UNABLE TO BE DETERMINED HOW MUCH FORCE OR TORQUE WAS PLACED ON THE ET TUBE AND ANCHORFAST DEVICE DURING THE TURNING OF THE PATIENT THAT CAUSED THE SHUTTLE TO SEPARATE FROM THE TRACK. . THIS REPORT OR INFORMATION SUBMITTED DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, HOLLISTER INCORPORATED, OR HOLLISTER EMPLOYEE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WAS BEING TURNED THE SHUTTLE CLAMP HOLDING THE ENDOTRACHEAL TUBE DISENGAGED FROM THE TRACK RESULTING IN EXTUBATION. THE PATIENT WAS REINTUBATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention