BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ENDOTRACHEAL TUBE, HVT, 8.0

    MDR report key: 3061267 · Received April 10, 2013

    Report

    Report Number
    3003898360-2013-00130
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 21, 2013
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER PROVIDED BY THE CUSTOMER WAS NOT A VALID LOT NUMBER. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE ESTABLISHED. MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE CUFF WAS DIFFICULT TO INFLATE PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148398 HUDSON ENDOTRACHEAL TUBE, HVT, 8.0 ET TUBE BTR TELEFLEX 01E120055

    Patients

    Seq Age Sex Outcome Treatment
    1