BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 3849677 · Received June 4, 2014

    Report

    Report Number
    1119193-2014-00011
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 4, 2014
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL WAS UNABLE TO PROVIDE INFORMATION AS TO WHETHER EXCESSIVE FORCE MAY HAVE BEEN APPLIED DURING THE PATIENT REPOSITIONING FOR THE BATH. HOLLISTER WILL CONTINUE TO EVALUATE THE PERFORMANCE OF THE ANCHORFAST DEVICE IN OUR POST MARKET SURVEILLANCE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6), 2014, THE PATIENT WAS ADMITTED TO ICU WITH ACUTE AND CHRONIC RESPIRATORY FAILURE. AN ANCHORFAST DEVICE WAS APPLIED AND WAS IN USE FOR APPROXIMATELY 72 HOURS. THE PATIENT WAS BEING POSITIONED FOR A BATH WHEN THE STAFF HEARD A SNAP. THEY DID NOT SEE THE BREAKAGE AT THE TIME THAT IT OCCURRED BUT THEY OBSERVED THAT THE NOTCHED ARE ON THE CLAMP CLOSEST TO THE TRACK HAD SNAPPED AND THE DEVICE SEPARATED. THE PATIENT SELF EXTUBATED AND REQUIRED REINTUBATION WHICH WAS COMPLETED WITH NO CHANGE IN PATIENT STATUS OR DESATURATION. THE HOSPITAL DID NOT KNOW WHETHER EXCESSIVE TORQUE MAY HAVE BEEN APPLIED DURING THE PATIENT REPOSITIONING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328027 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9799

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention