BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ENDOTRACHEAL TUBE, HVT, 8.0

    MDR report key: 3072653 · Received April 19, 2013

    Report

    Report Number
    3003898360-2013-00180
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    March 21, 2013
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: WHEN THE DOCTOR OPENED THE PACKAGE HE NOTICED DIFFICULTY IN THE INFLATION OF THE CUFF. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169421 HUDSON ENDOTRACHEAL TUBE, HVT, 8.0 ET TUBE BTR TELEFLEX 01E1200450

    Patients

    Seq Age Sex Outcome Treatment
    1