BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN NEEDLES

    MDR report key: 2973901 · Received February 21, 2013

    Report

    Report Number
    MW5029034
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 21, 2013
    Manufacturer
    SMITH MEDICAL
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    NURSES NOTICED A RUST LIKE RESIDUE IN THE NEEDLES. THIS WAS REPORTED TO THE MFR WHO SAYS IT IS NOT RUST. NEEDLES WERE RETURNED TO MFR FOR CREDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76346 INSULIN NEEDLES FMI SMITH MEDICAL 442-9-1
    76347 INSULIN NEEDLES FMI SMITH MEDICAL 442-9-5A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other