BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/CF TRACHEAL TUBE, 7.5MM

    MDR report key: 3021044 · Received March 20, 2013

    Report

    Report Number
    3003898360-2013-00108
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 6, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    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 CAN NOT 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 NURSE FOUND AN AIR LEAK FROM THE CUFF DURING FUNCTIONAL INSPECTION PRIOR TO USE ON A PATIENT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116303 HUDSON SHERIDAN/CF TRACHEAL TUBE, 7.5MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01H110044

    Patients

    Seq Age Sex Outcome Treatment
    1