BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITHS MEDICAL BLUE LINE ULTRA TRACHEOSTOMY KIT

    MDR report key: 8545277 · Received April 24, 2019

    Report

    Report Number
    3012307300-2019-02227
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    March 18, 2019
    Report Date
    April 24, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    OGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT WHILE A PATIENT WAS UNDER LOCAL ANESTHESIA, A SMITHS MEDICAL TRACHEAL TUBE KIT WAS USED. WHEN THE BALLOON AIR BAG CUTTING KIT WAS IMPLANTED, THE AIR BAG WAS FOUND TO BE LEAKING, AND A NEW TRACHEAL KIT WAS IMMEDIATELY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337197 SMITHS MEDICAL BLUE LINE ULTRA TRACHEOSTOMY KIT TRACHEOSTOMY OGW SMITHS MEDICAL ASD, INC. 3615719

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention