BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN UNCUFFED TRACHEAL TUBE

    MDR report key: 2960550 · Received January 23, 2013

    Report

    Report Number
    3003898360-2013-00045
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DHR (DEVICE HISTORY RECORD) 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. TELEFEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE USER FACILITY REPORTS HAVING AIR LEAK ISSUES WITH THE DEVICE DURING USE, IN THE NICU. THE PT WAS EXTUBATED AND RE-INTUBATED WITH A DIFFERENT ENDOTRACHEAL TUBE. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32667 HUDSON SHERIDAN UNCUFFED TRACHEAL TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01H1200401

    Patients

    Seq Age Sex Outcome Treatment
    1