BEUDAMED
    FDA Adverse Event Injury Summary report: N

    73 JOH - BLUE LINE INNER CANNULAE

    MDR report key: 881403 · Received July 10, 2007

    Report

    Report Number
    1217052-2007-00071
    Event Type
    Injury
    Date Received
    July 10, 2007
    Date of Event
    June 4, 2007
    Report Date
    June 11, 2007
    Manufacturer
    MFG FOR SMITHS MEDICAL BY: SMITHS MED INT'L LTD.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THE INNER CANNULA IS TOO LONG AND WHEN INSERTED INTO THE PT, THE PT TURNED BLUE AND STARTED VIOLENTLY COUGHING. PT HAD TO BE TRANSPORTED IN AN AMBULANCE TO THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 73 JOH - BLUE LINE INNER CANNULAE ACCESSORY TO TRACHEOSTOMY TUBE AND TUBE CUFF JOH MFG FOR SMITHS MEDICAL BY: SMITHS MED INT'L LTD. * 119772

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention PROFILE BLUE LINE 100/782/080 TRACHEOSTOMY TUBE