BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NASAL PREFORMED TRACHEAL TUBE

    MDR report key: 2971549 · Received January 31, 2013

    Report

    Report Number
    3003898360-2013-00056
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION AT THE TIME OF THIS REPORT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE ENDOTRACHEAL TUBE WAS TESTED AND CONFIRMED FOR PATENCY. THE NURSE ALLEGES THAT DURING AN ATTEMPT TO INTUBATE SHE COULD NOT GET A GOOD SEAL AND UPON EXTUBATION THE NURSE ALLEGES THAT THE CUFF HAD TORN. THE TUBE WAS REPLACED WITH THE SAME LOT NUMBER AND THE SAME INCIDENT ALLEGEDLY OCCURRED. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43561 HUDSON NASAL PREFORMED TRACHEAL TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01K1200235

    Patients

    Seq Age Sex Outcome Treatment
    1