BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER (BOUGIE)

    MDR report key: 1746145 · Received February 19, 2010

    Report

    Report Number
    1036445-2010-01016
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    January 10, 2010
    Report Date
    February 18, 2010
    Manufacturer
    MEDITEC DEVICES
    Product Code
    BWB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ENDOTRACHEAL TUBE INTRODUCER WAS USED TO EXCHANGE THE ENDOTRACHEAL TUBE THAT WAS PLACED IN PT'S TRACHEA. PT'S AIRWAY WAS DIFFICULT. ONCE PLACED IN THE ENDOTRACHEAL TUBE, THE INTRODUCER BROKE INTO TWO PIECES. ALL CONTENTS OF THE BLUE ENDOTRACHEAL TUBE WERE REMOVED WITH THE ENDOTRACHEAL TUBE UNDER DIRECT LARYNGOSCOPE. ANOTHER BLUE ENDOTRACHEAL TUBE WAS USED WITHOUT DIFFICULTY TO PLACE A NEW ENDOTRACHEAL TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRODUCER (BOUGIE) ENDOTRACHEAL TUBE INTRODUCER BWB MEDITEC DEVICES 9-0212-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR