BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE

    MDR report key: 957283 · Received December 5, 2007

    Report

    Report Number
    1217052-2007-00161
    Event Type
    Malfunction
    Date Received
    December 5, 2007
    Report Date
    November 26, 2007
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVALUATIONS: THIS NEEDLE IS SUPPLIED FROM TERUMO MEDICAL CORP AND THEY HAVE BEEN NOTIFIED OF THIS EVENT. A COMPLETE INVESTIGATION IS NOT ABLE TO BE PERFORMED AS THE USER FACILITY DID NOT SAVE THE SAMPLE. A REVIEW OF OUR COMPLAINTS DATABASE SHOWS THIS TO BE THE SECOND REPORT, OF NEEDLE OUT OF EPOXY, ON THIS NEEDLE. WE HAVE PREVIOUSLY HAD REPORTS OF THIS NATURE (FOR DIFFERENT NEEDLES). AT LEAST THREE OF THE REPORTS, WHEN THE SAMPLE WAS EXAMINED, THEY WERE NOT VALID AND LIKELY AN EVENT OF THE USER NOT SECURING THE CONNECTIONS PER THE INSTRUCTIONS FOR USE. THERE IS NO WAY TO DETERMINE IF THIS REPORT IS VALID WITHOUT THE ACTUAL SAMPLE.

    Description of Event or Problem · 1

    USER ALLEGES, ONE INCIDENT OF THE HYPODERMIC NEEDLE ADHESIVE SEAL, BETWEEN THE METAL AND PLASTIC, NOT HOLDING THUS ALLOWING NEEDLE TO DISASSEMBLE WHEN THEY OPENED THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE 80 FMI - ACCESSORY TO HYPODERMIC NEEDLES FMI SMITHS MEDICAL ASD, INC. 1071580

    Patients

    Seq Age Sex Outcome Treatment
    1 YR