BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAVE

    MDR report key: 1031616 · Received April 16, 2008

    Report

    Report Number
    MW5006304
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 16, 2008
    Manufacturer
    ICU MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BLUE CLAVE CONNECTOR LEAKED BLOOD OUT OF THE VALVE AFTER IT WAS CONNECTED TO THE HUB OF A 20 GAUGE INTROCAN SAFETY IV CATHETER. THE CLAVE WAS CHANGED AFTER THE LEAKY VALVE WAS DISCOVERED, WHICH WAS IMMEDIATELY AFTER IT WAS CONNECTED TO THE IV CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVE IV CONNECTOR FPA ICU MEDICAL 56-252-SN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability