BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUCTIONAID PROFILE TRACHEOSTOMY TUBE

    MDR report key: 960886 · Received November 30, 2007

    Report

    Report Number
    1217052-2007-00158
    Event Type
    Death
    Date Received
    November 30, 2007
    Date of Event
    November 15, 2007
    Report Date
    November 19, 2007
    Manufacturer
    MFG FOR SMITHS MED BY: SMITHS MED INT'L LTD.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL INT'L LTD., HAS BEEN NOTIFIED OF AN EVENT USER ALLEGES A COMPETITOR'S SPEAKING VALVE WAS ATTACHED TO 100/515/060(UNFENESTRATED), WHICH PREVENTED THE PT'S BREATHING AND RESULTED IN DEATH. THE DETAILS ARE AS FOLLOWS: A SHILEY TRACHEOSTOMY TUBE (FENESTRATED) HAD BEEN USED ON THE PT. THE PT HAD A LOT OF SPUTUM AND NEEDED TO SUCTION FREQUENTLY. THE HOSP STOPPED USING THE FENESTRATED TUBE AS SUCTION CATHETER TIP TENDS TO BE TRAPPED IN THE OPENING IN THE TUBE. IN 2007, A 100/515/060 WAS INSERTED. A CLOSED VENTILATION SUCTION CATHETER WAS ATTACHED TO THE TUBE. A SPEAKING VALVE WAS ACCIDENTALLY ATTACHED TO THE PT BY A NURSE. THE PT DIED. EVENT OCCURRED IN THE HOSPITAL IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTIONAID PROFILE TRACHEOSTOMY TUBE 73 JOH - BREATHING TUBE JOH MFG FOR SMITHS MED BY: SMITHS MED INT'L LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death CLOSED VENTILATION SUCTION CATHETER| SPEAKING VALVE