BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NASAL PREFORMED TRACHEAL TUBE

    MDR report key: 3082311 · Received April 8, 2013

    Report

    Report Number
    3003898360-2013-00126
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 17, 2013
    Report Date
    March 15, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT 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, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED, VIA ADVERSE EVENT REPORT, AS: THE BALLOON OF THE ENDOTRACHEAL TUBE WOULD NOT INFLATE AFTER BEING INSERTED. SEVERAL ENDOTRACHEAL TUBES WERE USED PRIOR TO THE PATIENT BEING SUCCESSFULLY INTUBATED. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144357 HUDSON NASAL PREFORMED TRACHEAL TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01K1100382

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR