BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT ACCESS NEEDLE

    MDR report key: 6363870 · Received February 28, 2017

    Report

    Report Number
    6363870
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    February 9, 2017
    Report Date
    February 24, 2017
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON DE ACCESS THE SAFETY MECHANISM FAILED TO ENGAGE LEAVING THE NEEDLE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146862 PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS, INC. 0142075 ASAYS0018

    Patients

    Seq Age Sex Outcome Treatment
    1 CHEMOTHERAPY| NO