BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE

    MDR report key: 1958268 · Received January 6, 2011

    Report

    Report Number
    MW5018922
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CONDENSATION FOUND IN A SINGLE PACKAGE OF GENIE CLOSED VIAL ACCESS DEVICE -CLAVE- WITH LOT # 1983882. PRODUCT IS FROM ICU MEDICAL INC. (B)(4) WAS CONTACTED BY PHONE AND THIS SINGLE PACKAGE WAS HANDED TO HIM THIS AFTERNOON FOR HIM TO REPORT THE ISSUE TO HIS COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVE GENIE CLOSED VIAL ACCESS DEVICE FPA ICU MEDICAL INC. 1983882

    Patients

    Seq Age Sex Outcome Treatment
    1