BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE LINK NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLAC

    MDR report key: 3893483 · Received June 13, 2014

    Report

    Report Number
    3893483
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 30, 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

    ATTEMPTING TO INFUSE FFP VIA PIV (PERIPHERAL IV) WITH A ONE LINK CONNECTOR. FFP WAS NOT DRIPPING; ATTEMPTED TO FLUSH IV. SINCE IV DID NOT FLUSH, CHANGED THE ONE LINK CONNECTOR. PIV FLUSHED AS NORMAL. ATTACHED THE FFP TO INFUSE; IT WOULD NOT DRIP IN, SO REMOVED THE ONE LINK CONNECTOR AND ATTACHED THE FFP LINE DIRECTLY TO THE PIV EXTENSION HUB. DRIPPED IN CORRECTLY.THIS FACILITY HAS EXPERIENCED MULTIPLE SIMILAR EVENTS WITH THIS TYPE OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351246 ONE LINK NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLAC SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR