BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUBER NEEDLE

    MDR report key: 2223361 · Received August 17, 2011

    Report

    Report Number
    2223361
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 17, 2011
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A HUBER NEEDLE WAS PLACED IN THE PATIENT ON DAY 2 OF THE PATIENT'S CHEMOTHERAPY. SHE RECEIVED ZOFRAN AND DECADRON AND HAD NO ISSUES. ON DAY 3, WHEN THE ETOPOSIDE WAS RUNNING (ABOUT 15 MINUTES INTO IT), SHE NOTED "LEAKING ON HER SHIRT". STAFF STOPPED THE INFUSION AND CHANGED THE CAP, BUT WHEN FLUSHING, THERE WAS LEAKING OUT OF THE PLASTIC PORTION WHERE CAP IS INSERTED, NOT FROM THE CAP AREA. THIS NEEDLE WAS REMOVED AND ANOTHER HUBER INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUBER NEEDLE HUBER NEEDLE FPA BARD ACCESS SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *