BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARYNG-O-JET KIT 4%

    MDR report key: 2140529 · Received June 21, 2011

    Report

    Report Number
    MW5021101
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 21, 2011
    Manufacturer
    INTERNATIONAL MEDICATION SYSTEMS, LIMITED
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING E.T. INTUBATION FOR ELECTIVE SURGERY, THE ANESTHESIOLOGIST WAS ADVANCING THE LIDOCAINE TOPICAL INFUSION DEVICE (LTA) THROUGH THE ET TUBE, AND THE PLASTIC TIP BROKE OFF IN THE PT'S TRACHEA. UNABLE TO VISUALIZE IT WITH DIRECT LARYNGOSCOPY, A PULMONOLOGIST WAS EMERGENTLY CONTACTED AND ARRIVED TO PERFORM A BRONCHOSCOPY TO REMOVE THE BROKEN TIP, WHICH WAS IN HER RIGHT MAINSTEM BRONCHUS. AFTER MULTIPLE ATTEMPTS, THEY WERE ABLE TO REMOVE THE PLASTIC TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARYNG-O-JET KIT 4% FMF INTERNATIONAL MEDICATION SYSTEMS, LIMITED DJ068B1

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening