BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK IV ACCESS SYSTEM INJECTION SITE

    MDR report key: 4120698 · Received September 19, 2014

    Report

    Report Number
    4120698
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    April 29, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    RN WENT INTO THE ROOM TO ANSWER AN IV ALARM AND FOUND THE IV CAP WAS DISCONNECTED FROM THE T CONNECTOR, THE NONO SLEEVE WAS SATURATED IN BLOOD AND THERE WAS BLOOD ON THE BED. THE CAP WAS REPLACED, THE IV FLUSHED WELL AND THE LINE WAS RE-ATTACHED. SECOND RN HAD BEEN IN THE ROOM PREVIOUSLY AND PLACED THE NONO SLEEVE. SHE HAD CHECKED ALL THE CONNECTIONS AND THEY WERE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583215 INTERLINK IV ACCESS SYSTEM INJECTION SITE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 2N3399 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR