BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/CF TRACHEAL TUBE, 7.0MM

    MDR report key: 3013079 · Received March 15, 2013

    Report

    Report Number
    3003898360-2013-00098
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    August 27, 2012
    Report Date
    March 1, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON THE REPORTED LOT NUMBER. THE DHR INVESTIGATION 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 DOCTOR OPENED A NEW 5-10114 TRACHEAL TUBE AND WAS UNABLE TO INFLATE THE CUFF. ANOTHER TRACHEAL TUBE WAS USED. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110834 HUDSON SHERIDAN/CF TRACHEAL TUBE, 7.0MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01G1100097

    Patients

    Seq Age Sex Outcome Treatment
    1