BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK SYSTEM NON-DEHP EXTENSION SET

    MDR report key: 2792297 · Received September 19, 2012

    Report

    Report Number
    2792297
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    July 7, 2012
    Report Date
    September 19, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THERE IS A PROBLEM WITH THE IV CONNECTIONS. THE BLUE HUBS ARE NOT TIGHT ENOUGH COMING OUT OF THE PACKAGE, RESULTING IN THE BLUE HUB DISCONNECTING OFF THE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK SYSTEM NON-DEHP EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR KDJ BAXTER HEALTHCARE CORPORATION 2H8671 R12A05011

    Patients

    Seq Age Sex Outcome Treatment
    1 *