BEUDAMED
    FDA Adverse Event Summary report: N

    ENDOTRACHEAL TUBE INTRODUCER

    MDR report key: 1616107 · Received February 12, 2010

    Report

    Report Number
    1616107
    Date Received
    February 12, 2010
    Date of Event
    February 8, 2010
    Report Date
    February 12, 2010
    Manufacturer
    SUN MED
    Product Code
    BTR
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ANESTHESIA INSERTED ET TUBE AND ENDOTRACHEAL TUBE INTRODUCER "STYLET" IN OR. APPROXIMATELY 3 1/2 HOURS LATER THE PATIENT COUGHED UP A SMALL BLUE PLASTIC PIECE, THOUGHT TO BE FROM THIS DEVICE. APPEARS TO HAVE BROKEN OFF AT THE CURVED TIP. APPROXIMATELY 1 INCH BROKEN OFF. TIP RETAINED, STYLET AND ORIGINAL PACKAGE NOT RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE INTRODUCER ENDOTRACHEAL TUBE INTRODUCER BTR SUN MED UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR