BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO SYRINGE AND NEEDLE WITH NEEDLE PROTECT

    MDR report key: 812721 · Received January 19, 2007

    Report

    Report Number
    1217052-2007-00009
    Event Type
    Malfunction
    Date Received
    January 19, 2007
    Date of Event
    December 1, 2006
    Report Date
    December 22, 2006
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 EVENT SAMPLE. OUR COMPLAINTS HISTORY SHOWS SEVERAL REPORTS THAT, WHEN THE RETURNED SAMPLE WAS EXAMINED, THE REPORT WAS NOT VALID AND LIKELY AN EVENT OF THE USER NOT SECURING THE CONNECTIONS PER THE INSTRUCTIONS FOR USE. THIS REPORT CANNOT BE CONFIRMED.

    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. NEEDLE WAS ABLE TO BE RETRIEVED FROM PT WITHOUT MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *