BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE LINE ULTRA PERCUTANEOUS TRACHEOSTOMY KIT WITHOUT FORCEPS, 8.0MM - 100/543/0

    MDR report key: 8054727 · Received November 9, 2018

    Report

    Report Number
    3012307300-2018-00470
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    September 20, 2018
    Report Date
    November 8, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY HAD FALSE TRACT CREATED. THE PATIENT REPORTEDLY DESATURATED RAPIDLY TO 30 PERCENT, AND AN ENDOTRACHEAL INTUBATION PERFORMED TO PREVENT HYPOXIC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894880 BLUE LINE ULTRA PERCUTANEOUS TRACHEOSTOMY KIT WITHOUT FORCEPS, 8.0MM - 100/543/0 TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3361642

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention