BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE ALUMINIUM STYLETTE

    MDR report key: 1696676 · Received May 17, 2010

    Report

    Report Number
    2183650-2010-00004
    Event Type
    Injury
    Date Received
    May 17, 2010
    Date of Event
    December 14, 2009
    Report Date
    May 14, 2010
    Manufacturer
    MEDITEC DEVICES
    Product Code
    BSR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SINGLE USE ALUMINUM STYLETTE WAS USED DURING A DIFFICULT INTUBATION ON A MORBIDLY OBESE PT. THE INTUBATION GUIDE (STYLETTE) WAS MANEUVERED WHILE INSERTED INTO THE ENDOTRACHEAL TUBE, THE DISTAL END BROKE OFF INSIDE THE TUBE, SLIDED THROUGH THE TUBE AND WENT INTO THE PT'S TRACHEA. FIBROBRONCHOSCOPY WAS PERFORMED IN ORDER TO REMOVE THE REMAINING PART FROM THE PT. NO INFECTION RESULTED AFTER THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE ALUMINIUM STYLETTE STYLETTE BSR MEDITEC DEVICES 9-0204-25 MD011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other| R