BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOSTAR

    MDR report key: 3925195 · Received June 18, 2014

    Report

    Report Number
    3925195
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A NEOSTAR PLACED AND APPROXIMATELY TWO WEEKS LATER IT WAS NOTED THAT THE NEOSTAR HAD A SMALL PINHOLE IN THE EXTERNAL LUMEN OF THE CATHETER. THE NEOSTAR WAS EXCHANGED. THE VENDOR WAS NOTIFIED. ALL PRODUCTS WITH THE SAME LOT# WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358238 NEOSTAR CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO ANGIODYNAMICS, INC. * 47132663

    Patients

    Seq Age Sex Outcome Treatment
    1 *