BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE INTRODUCER

    MDR report key: 1817046 · Received April 8, 2010

    Report

    Report Number
    2183650-2010-00003
    Event Type
    Malfunction
    Date Received
    April 8, 2010
    Date of Event
    February 8, 2010
    Report Date
    April 7, 2010
    Manufacturer
    MEDITEC DEVICES
    Product Code
    BWB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ANESTHESIA INSERTED ET TUBE IN OPERATING ROOM. THREE AND HALF HOURS LATER, THE PT COUGHED UP A SMALL BLUE PLASTIC PIECE, THOUGHT TO BE FROM THIS DEVICE. APPEARS TO HAVE BROKEN OFF AT THE CURVED TIP. APPROXIMATELY ONE INCH BROKE OFF. TIP RETAINED, STYLET AND ORIGINAL PACKAGE NOT RETAINED. NO ELECTROPHYSIOLOGY PROCEDURE PERFORMED. ORIGINAL INTENDED PROCEDURE WAS INTUBATION FOR CERVICAL SPINE EXPLORATION AND HARDWARE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE INTRODUCER ENDOTRACHEAL TUBE INTRODUCER BWB MEDITEC DEVICES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR