BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 3728528 · Received April 7, 2014

    Report

    Report Number
    1119193-2014-00007
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 4, 2014
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOLLISTER EVALUATION INDICATED THAT THE DEVICE SHUTTLE HAD MOST LIKELY BEEN FORCED OFF OF THE END OF THE SHUTTLE TRACK WHILE IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS APPLIED TO THE PATIENT ON (B)(6) 2014. A VENTILATOR ASSESSMENT WAS PERFORMED BY THE RESPIRATORY THERAPIST INCLUDING TUBE HOLDER BEING MOVED AS PER PROTOCOL, AIRWAY WAS SUCTIONED AND VERIFICATION THE AIRWAY WAS INTACT AND SHE LEFT THE ROOM. THE NURSES GAVE A BATH AND THEN CALLED THE RESPIRATORY THERAPIST BACK TO THE ROOM AS THE ANCHORFAST DID NOT LOOK RIGHT. IT WAS REALIZED THAT THE ANCHORFAST HAD COME APART WITH THE CLAMP SEPARATING FROM THE DEVICE. IT WAS REPLACED WITH A NEW ANCHORFAST DEVICE. THE PATIENT DID NOT EXTUBATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207067 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9799

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention