BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUBER PLUS NON-CORING NEEDLE SAFETY INFUSION SET

    MDR report key: 6109094 · Received November 17, 2016

    Report

    Report Number
    6109094
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 11, 2016
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD EXPIRED AND THE RN REMOVED PORT-A-CATH ACCESS. THE HUBER NEEDLE SAFETY FEATURE DID NOT ACTIVATE AND THE NEEDLE EVEN BENT BACK TOWARD RN. THE RN SUSTAINED A NEEDLE STICK INJURY ON HER FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761647 HUBER PLUS NON-CORING NEEDLE SAFETY INFUSION SET NEEDLE, HYPODERMIC FMI BARD ACCESS SYSTEMS, INC. REAT 1560

    Patients

    Seq Age Sex Outcome Treatment
    1