BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ENDOTRACHEAL TUBE HVT, 8.0

    MDR report key: 3072655 · Received April 19, 2013

    Report

    Report Number
    3003898360-2013-00176
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 21, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE DOCTOR OPENED THE PACKAGE PRIOR TO PATIENT USE AND NOTICED DIFFICULTY TO DEFLATE THE CUFF. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169811 HUDSON ENDOTRACHEAL TUBE HVT, 8.0 ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01E1200451

    Patients

    Seq Age Sex Outcome Treatment
    1