BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT ACCESS NEEDLE

    MDR report key: 8883045 · Received August 12, 2019

    Report

    Report Number
    8883045
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 24, 2019
    Report Date
    July 24, 2019
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    2 PORT NEEDLES; ONE FILLED WITH AIR AND 1 APPEARED TO HAVE DEBRIS IN TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679291 PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS, INC. LH-0030 ASCYF016

    Patients

    Seq Age Sex Outcome Treatment
    1