BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE INTRODUCER

    MDR report key: 3947539 · Received July 1, 2014

    Report

    Report Number
    1036445-2014-00004
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 1, 2014
    Manufacturer
    FBK MEDICAL
    Product Code
    BSR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOUGIE BROKE DURING PATIENT USE. THE PATIENT NOTICED AFTER BEING RELEASED FROM HOSPITAL. RETURNED TO EMERGENCY ROOM FOR REMOVAL AND WAS SENT TO OPERATING ROOM AND RE-INTUBATED. THE REMAINING FRAGMENT WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381958 ENDOTRACHEAL TUBE INTRODUCER ET TUBE INTRODUCER/BOUGIE BSR FBK MEDICAL 9-0212-70 PRN05-3446

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention