BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 2061164 · Received April 13, 2011

    Report

    Report Number
    1119193-2011-00007
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    HOLLISTER, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNABLE TO BE DETERMINED WHAT EXACT PIECE SPONTANEOUSLY BROKE. REPEATED CALLS TO THE HOSPITAL HAVE GONE UNANSWERED.

    Description of Event or Problem · 1

    MEDWATCH: IT WAS REPORTED THAT "THE ANCHORFAST ORAL ET TUBE HOLDER USES A STRAP AND CLIP TO HOLD AN ORAL ENDOTRACHEAL TUBE IN PLACE. PATIENT'S RN NOTED INCREASED RESPIRATORY DISTRESS AND CHANGE IN VITAL SIGNS. THE PATIENTS ET TUBE HAD SLIPPED FROM ITS DESIRED POSITION OF 26CM TO 20CM, WHICH ALLOWED THE CUFF TO BE ABOVE THE VOCAL CORDS, WHICH LEAD TO A LOSS OF A STABLE AIRWAY. PATIENT REQUIRED A BRONCHOSCOPE TO ADVANCE THE ET TUBE BACK TO THE CORRECT POSITION. BROKEN ANCHORFAST WAS REPLACED WITH A NEW ONE. THE CLIP THAT HOLDS THE STRAP AROUND THE TUBE HAD SNAPPED OFF SPONTANEOUSLY."

    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 Required Intervention