BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO SYRINGE AND NEEDLE WITH NEEDLE PROTECT

    MDR report key: 761658 · Received August 4, 2006

    Report

    Report Number
    1217052-2006-00043
    Event Type
    Malfunction
    Date Received
    August 4, 2006
    Date of Event
    June 29, 2006
    Report Date
    July 6, 2006
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 FIRST 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. THIS FACILITY HAS TWICE SENT BACK WHAT THEY REPORTED AS NEEDLE OUT OF EPOXY AND WE HAVE BEEN ABLE TO CONFIRM THAT IS NOT VALID.

    Description of Event or Problem · 1

    USER ALLEGES THEY HAD ONE EVENT OF THE HYPODERMIC NEEDLE ADHESIVE SEAL, BETWEEN THE METAL AND PLASTIC, NOT HOLDING, THUS ALLOWING NEEDLE TO DISASSEMBLE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPODERMIC NEEDLE-PRO SYRINGE AND NEEDLE WITH NEEDLE PROTECT ACCESSORY TO HYPODERMIC NEEDLES FMI SMITHS MEDICAL ASD, INC. NA K500469

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN