BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS

    MDR report key: 3164275 · Received May 15, 2013

    Report

    Report Number
    3164275
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 7, 2013
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    OJA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE PORT WAS CRACKED. AIR IS ABLE TO ENTER THE LINE AND CAUSE BUBBLES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IV CONNECTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215964 MAXPLUS CONNECTOR, TUBING, IV OJA CAREFUSION 303, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES