BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE INTRODUCER

    MDR report key: 3003858 · Received March 12, 2013

    Report

    Report Number
    1036445-2013-00038
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    FBK MEDICAL
    Product Code
    BSR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH MALLAMPATI CLASS III, SMALL MOUTH OPENING, THYROMENTAL DISTANCE 2 FINGER BREADTHS, WITH LIMITED NECK MOBILITY, WAS INTUBATED WITH ENDOTRACHEAL TUBE INTRODUCER DEVICE. UPON REMOVAL OF ENDOTRACHEAL TUBE DEVICE, IT WAS NOTED THAT DEVICE BROKE OFF AT 12CM AND WENT TO THE PT'S TRACHEA. THE BROKEN PIECE WAS REMOVED USING A COMBINATION OF FLEXIBLE AND RIGID BRONCHOSCOPY. PT REMAINED INTUBATED FOR 72HRS FOLLOWING SURGERY. EXTUBATION WAS SUCCESSFUL, PT WAS DISCHARGED AND HAS BEEN DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103432 ENDOTRACHEAL TUBE INTRODUCER BSR FBK MEDICAL 9-0212-70 PRN05-3446

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention