BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS

    MDR report key: 4173139 · Received September 30, 2014

    Report

    Report Number
    4173139
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    February 4, 2014
    Report Date
    September 30, 2014
    Manufacturer
    CAREFUSION 303, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NEW CAREFUSION EXTENSION SETS HAVE A DESIGN FLAW THAT IS CREATING A BIO HAZARD. THE HUBS WHEN DISCONNECTED FROM A SYRINGE OR VACUTAINER OR ANY ACCESS DEVICE DO NOT CLOSE IMMEDIATELY. THIS CAUSES LEAKAGE OF FLUID EITHER DRUGS/SALINE OR BLOOD. THIS IS CAUSING UNNECESSARY EXPOSURE TO BLOOD BORNE PATHOGENS FOR STAFF AND PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607542 MAXPLUS SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC MP9001-C M609MP9001

    Patients

    Seq Age Sex Outcome Treatment
    1 *