BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK IV ACCESS SYSTEM

    MDR report key: 4131214 · Received September 19, 2014

    Report

    Report Number
    4131214
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    May 12, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    IV CAP BECAME UNSCREWED FROM THE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585225 INTERLINK IV ACCESS SYSTEM SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR