BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 3787823 · Received May 2, 2014

    Report

    Report Number
    1119193-2014-00008
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 4, 2014
    Report Date
    May 2, 2014
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DESIGN HISTORY RECORDS WERE REVIEWED AND FOUND TO BE COMPLETE AND ACCURATE. A COMPLAINT TREND ANALYSIS WAS PERFORMED FROM (B)(4) 2011 TO (B)(4) 2014 AND FOUND NO OBVIOUS ADVERSE TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, AN INTUBATED PATIENT WAS WEARING AN ANCHORFAST ENDOTRACHEAL TUBE FASTENER DEVICE. THIS ORIGINAL DEVICE WAS DUE TO BE CHANGED AFTER A 5 DAY WEARTIME. THE RESPIRATORY THERAPIST REMOVED THE ORIGINAL ANCHORFAST DEVICE AND BEGAN INSTALLING A NEW ANCHORFAST DEVICE. WHEN PLACING AND APPLYING THE ANCHORFAST TO THE PATIENT THE CHEEK PAD FELL OFF OF THE DEVICE. ANOTHER ANCHOR FAST DEVICE WAS THEN APPLIED. THERE WAS NO INJURY AND THE PATIENT DID NOT EXTUBATE. THE RESPIRATORY THERAPIST NOTED SEVERAL OTHER ANCHORFAST BOXES WITH THE CHEEK PAD SEPARATED FROM THE DEVICE THAT WERE STILL IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264674 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9799

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention