BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSASAFE EXTENSION TUBING

    MDR report key: 4120699 · Received September 19, 2014

    Report

    Report Number
    4120699
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    April 26, 2014
    Report Date
    August 22, 2014
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    EXTENSION TUBING ACCESS PORT CRUMPLED WHILE BEING ACCESSED AND "PLUG" EXTENDED INTO THE TUBING, IT DID NOT TRAVEL IN THE TUBING AND NO FLUID ESCAPED FROM THE TUBING; HEPARIN WAS INFUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583270 VERSASAFE EXTENSION TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR