BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACH-EXE CLOSED SUTION SYSTEM

    MDR report key: 599694 · Received June 24, 2004

    Report

    Report Number
    1722214-2004-00011
    Event Type
    Malfunction
    Date Received
    June 24, 2004
    Report Date
    May 25, 2004
    Manufacturer
    SORENSON MEDICAL, INC.
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PRODUCT DEMONSTRATION IN A NON CLINICAL SETTING, THE ETT CONNECTOR WAS CLOSED ONTO THE CATHETER. THE DEMOSTRATOR FAILED TO COMPLETELY WITHDRAW THE CATHETER AND OVER ROTATED THE ERR CONNECTOR. THIS RESULTED IN THE TIP OF THE CATHETER BEING SHEARED OFF. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS ASSOCIATED WITH THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACH-EXE CLOSED SUTION SYSTEM 4.0/4.5 MM ETT CONNECTOR BSY SORENSON MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other