BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE LINK NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLAC

    MDR report key: 3893473 · Received June 13, 2014

    Report

    Report Number
    3893473
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    INFUSING 5% ALBUMIN 500ML. NOTED BLOOD ON FLOOR. THE ONE LINK CAP CAME OFF OF ONE OF THE PORTS OF THE TRIPLE LUMEN LINE. ESTIMATED BLOOD LOSS 20ML. ALBUMIN WOULD NOT FLOW WITH THE ONE LINK CAP ATTACHED TO THE LINE.THIS FACILITY HAS HAD MULTIPLE SIMILAR EVENTS WITH THIS DEVICE. FLUIDS GIVEN VIA IV DRIP, IV PUMP, AND IV PUSH ARE ABLE TO BE GIVEN WITHOUT THE ONE-LINK DEVICE ATTACHED. LINE PATENCY IS VERIFIED. WHEN THE ONE-LINK IS IN PLACE ON THE SAME LINES, THE DRIP, PUMP, PUSH WILL NOT GO IN AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351177 ONE LINK NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLAC SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORP. 7N8399 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR