BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 3052666 · Received April 11, 2013

    Report

    Report Number
    1119193-2013-00006
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    January 27, 2013
    Report Date
    April 11, 2013
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE SAMPLE OR LOT NUMBER, WE ARE UNABLE TO EVALUATE THE REPORTED INCIDENT. HOWEVER THE ADHESIVE ON THE ET TUBE IS A SECONDARY METHOD FOR SECURING THE TUBE WITH THE SECURITY CLAMP BEING THE PRIMARY SECUREMENT METHOD. IT IS POSSIBLE THAT EXCESSIVE FORCE ON THE DEVICE MAY HAVE OCCURRED WHEN THE PATIENT WAS TURNED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED: THE PATIENT WAS TURNED FOR CLEANING AND WHEN HE WAS RESUMED TO REGULAR POSITION THE NURSE NOTED THAT THERE WAS A LOSS OF END TIDAL CARBON DIOXIDE AND AUDIBLE AIR COMING FROM PATIENT'S MOUTH. THE ET TUBE HAD SLIPPED THROUGH THE ET TUBE STRAP OF THE ANCHORFAST ENDOTRACHEAL TUBE HOLDER CAUSING AN EXTUBATION. THE NURSE REPORTED THAT THE STRAP WAS TIGHT AROUND THE TUBE, IT WAS JUST THAT THE TUBE SLIPPED THROUGH THE STRAP. THE EXTUBATION LED TO A CODE AND THE PHYSICIAN WAS CALLED TO RE-INTUBATE. THE PATIENT IS STABLE WITH NO CHANGE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156939 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9799

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening