BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACHEAL TUBE (BOUGIE) INTRODUCER

    MDR report key: 1697367 · Received May 19, 2010

    Report

    Report Number
    1036445-2010-00071
    Event Type
    Injury
    Date Received
    May 19, 2010
    Date of Event
    April 18, 2010
    Report Date
    May 18, 2010
    Manufacturer
    FBK MEDICAL TUBING INC.
    Product Code
    BSR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    FOR RAPID INDUCTION FOR EMERGENT C-SECTION, PT WAS FOUND TO HAVE DIFFICULT AIRWAY DUE TO LIMITED HEAD TILT BECAUSE OF ARTHRITIS. INTRODUCER WAS USED IN EFFORT TO INTUBATE BUT WENT DOWN ESOPHAGUS. WHEN REMOVED ONLY ABOUT HALF OF THE BOUGIE WAS PRESENT. EMERGENT CASE WAS DONE WITH MASK/BAG AND IV. PULMONARY TEAM ARRIVED, INTUBATED WITH SCOPE, AND RETRIEVED REMAINDER OF INTRODUCER (ALTHOUGH IT WAS BRITTLE ENOUGH THAT A SECOND BREAK OCCURRED DURING THE REMOVAL). PT WAS LEFT INTUBATED AND OBSERVED IN ICU. THE PT WAS DISCHARGED IN GOOD CONDITION ON POD#3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACHEAL TUBE (BOUGIE) INTRODUCER BSR FBK MEDICAL TUBING INC. 9-0212-70 04-2999

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention