BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/HVT TRACHEAL TUBE

    MDR report key: 2901486 · Received January 3, 2013

    Report

    Report Number
    3003898360-2013-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 11, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON THE REPORTED LOT NUMBER. THE DHR DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE USER FACILITY REPORTS THAT THE ONE WAY VALVE IN THE PILOT BALLOON GETS STUCK. THEY ARE UNABLE TO INSERT OR REMOVE ANY AIR IN THE CUFF. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071 HUDSON SHERIDAN/HVT TRACHEAL TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01C1200405

    Patients

    Seq Age Sex Outcome Treatment
    1