BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERI-CATH CLOSED VENTILATION SYSTEM

    MDR report key: 1110943 · Received August 4, 2008

    Report

    Report Number
    9610530-2008-00029
    Event Type
    Injury
    Date Received
    August 4, 2008
    Report Date
    July 8, 2008
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THE THUMB VALVE IS GETTING STUCK, AND STAYING DOWN CAUSING CONTINUAL SUCTION TO PT AND MAKING PT UNABLE TO BREATHE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-CATH CLOSED VENTILATION SYSTEM 73 CAF - CATHETER, SUCTION/INSUFFLATION, TRACHEOBRONCHIAL BSY SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention