BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7" EXTENSION SET, CLAVE CONNECTOR

    MDR report key: 2883915 · Received December 13, 2012

    Report

    Report Number
    MW5028242
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ICU MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HIT HIS ARM ON BEDRAIL AND BLUE CONNECTION PORT BROKE OFF EXTENSION CLAVE CONNECTOR. BLOOD THEN CAME OUT OF LINE FROM VEIN. PT CALLED NURSE FOR HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7" EXTENSION SET, CLAVE CONNECTOR FPA ICU MEDICAL 18-720-SJ

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR