BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 1638366 · Received March 18, 2010

    Report

    Report Number
    1119193-2010-00001
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    February 16, 2010
    Report Date
    March 18, 2010
    Manufacturer
    HOLLISTER, INC.
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS VISUALLY INSPECTED AND IT WAS DETERMINED THAT A PORTION OF THE C-CLAMP ON THE SHUTTLE WAS MISSING FROM THE BOTTOM LEFT CORNER. THE PIECE BROKEN FROM THE CLAMP AND THE REMOVAL OF THE SHUTTLE FROM THE TRACK ARE THEORIZED TO HAVE BEEN THE RESULT OF THE APPLICATION OF A TWISTING FORCE, BUT THIS CAN NOT BE CONFIRMED. THIS REPORT OR INFO 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 A NURSE WAS PERFORMING OTHER DUTIES IN PT'S ROOM, SHE NOTED THE SHUTTLE HAD SEPARATED FROM THE TRACK. THE PT WAS FULLY SEDATED AND NO HARM TO THE PT OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1