BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD EXTENSION SET

    MDR report key: 5366234 · Received January 14, 2016

    Report

    Report Number
    5366234
    Event Type
    Malfunction
    Date Received
    January 14, 2016
    Date of Event
    December 23, 2015
    Report Date
    January 12, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE OF THE NEEDLELESS CONNECTORS IN THIS SET DOES NOT WORK. THE INTERNAL BLUE PORTION THAT COMPRESSES WHEN ACCESSED WITH A SYRINGE IS TURNED INCORRECTLY, WHICH PROHIBITS FLOW INTO THE SET. THIS HAS HAPPENED MULTIPLE TIMES. WHEN DISCOVERED, THE LINE MUST BE CHANGED. THESE SETS HAVE FAILED IN A NUMBER OF LOCATIONS IN OUR ORGANIZATION. ALL REMAINING STOCK OF THIS WERE RETURNED TO CAREFUSION ALONG WITH SAMPLE SETS FOR TESTING. NO PATIENTS WERE HARMED, BUT THERE WERE MANY FAILURES OF THIS PRODUCT. MANUFACTURER RESPONSE FOR EXTENSION SET WITH NEEDLELESS Y-SITE, MAXGUARD EXTENSION SET (PER SITE REPORTER): LOOKING AT PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24807 MAXGUARD EXTENSION SET IV ADMINISTRATION SET FPA CAREFUSION MX9175 15105719

    Patients

    Seq Age Sex Outcome Treatment
    1