BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT ACCESS NEEDLE

    MDR report key: 6457421 · Received April 4, 2017

    Report

    Report Number
    6457421
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Date of Event
    February 7, 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 DID NOT RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239250 PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS, INC. 0142010 ASARS0256

    Patients

    Seq Age Sex Outcome Treatment
    1 CHEMOTHERAPY| NO