BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE SWIVEL ELBOW WITH PORT AND CAP

    MDR report key: 1512834 · Received May 21, 2009

    Report

    Report Number
    1319447-2009-00001
    Event Type
    Malfunction
    Date Received
    May 21, 2009
    Date of Event
    February 7, 2009
    Report Date
    May 21, 2009
    Manufacturer
    INTERSURGICAL, INC.
    Product Code
    BZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SUCTION CAP ON THE DOUBLE SWIVEL ELBOW CONNECTOR CAME OPEN WHEN REMOVING A PT FROM AN AMBULANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE SWIVEL ELBOW WITH PORT AND CAP CONNECTOR, AIRWAY BZO INTERSURGICAL, INC. 1996 2071629

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention