BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 2424105 · Received January 20, 2012

    Report

    Report Number
    1119193-2012-00002
    Event Type
    Death
    Date Received
    January 20, 2012
    Report Date
    January 20, 2012
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE PATIENT'S MEDICAL CONDITION, A DNR WAS IN PLACE AND NO MEDICAL INTERVENTION WAS PROVIDED FOLLOWING THE EXTUBATION. IT CAN NOT BE DETERMINED HOW MUCH PULLING WAS ON THE ET TUBE AS A RESULT OF THE LACK OF SUPPORT ARM USAGE BY THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT IN HIS 70'S WAS INTUBATED FOR V FIB ARREST AND ANOXIC BRAIN INJURY. HE WAS ON A VENTILATOR AND THE ET TUBE WAS SECURED BY THE ANCHORFAST ENDOTRACHEAL ATTACHMENT DEVICE. THE PATIENT WAS INTUBATED FOR A TOTAL OF 7 DAYS. THE ET TUBE SLIPPED WHILE STILL BEING SECURED BY THE TUBE STRAP AND THE PATIENT BECAME EXTUBATED. THE CLINICAL COORDINATOR FELT IT WAS A LACK OF ADHESIVE QUALITY ON THE ANCHORFAST ET TUBE STRAP. THE PATIENT WAS GOING TO BE TERMINALLY EXTUBATED THE NEXT DAY AND WAS ON A DNR ORDER. THE FAMILY REQUESTED THAT HE NOT BE REINTUBATED AND HE EXPIRED. THE CLINICAL COORDINATOR SAID THE DEPARTMENT DOES NOT USE SUPPORT ARMS FOR THE VENTILATION TUBING BUT USES A TOWEL ROLL ON THE PATIENT'S CHEST TO SUPPORT THE TUBING. SHE STATED THAT THERE COULD HAVE BEEN PULLING ON THE ET TUBE AS A RESULT OF THE LACK OF SUPPORT ARM USAGE.

    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 Death| O