BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 3813935 · Received May 15, 2014

    Report

    Report Number
    1119193-2014-00010
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS AVAILABLE AND NO SPECIFIC INCIDENT WAS DETAILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SEVERAL INSTANCES OF THE CLAMP SEPARATING FROM THE TRACK AND THE ET TUBE STRAP BREAKING. NO FURTHER INFORMATION WAS PROVIDED. THERE WERE NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292203 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9799

    Patients

    Seq Age Sex Outcome Treatment
    1