BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/HVT TRACHEAL TUBE

    MDR report key: 2901485 · Received January 3, 2013

    Report

    Report Number
    3003898360-2013-00007
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    October 26, 2012
    Report Date
    December 10, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE TUBE MARKINGS DISAPPEARED DURING USE. THE PT WAS RE-INTUBATED. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509 HUDSON SHERIDAN/HVT TRACHEAL TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01D1100329

    Patients

    Seq Age Sex Outcome Treatment
    1