BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICU MEDICAL INC

    MDR report key: 399301 · Received June 10, 2002

    Report

    Report Number
    MW1025285
    Event Type
    Other
    Date Received
    June 10, 2002
    Date of Event
    May 7, 2002
    Report Date
    June 10, 2002
    Manufacturer
    ABBOTT LAB
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CLAVE CONNECTOR DISLODGED FROM EXTENSION SET TUBING WHERE PERMANENTLY ATTACHED. IV TO PLUM BUMP AND INFUSING AT NORMAL RATE. POTENTIAL FOR EXCESSIVE BLEEDING OR CLOTTING OFF OF IV SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICU MEDICAL INC CLAVE EXTENSION SET FPA ABBOTT LAB 12315 *

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Other