BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO SYRINGE AND NEEDLE WITH NEEDLE PROTECT

    MDR report key: 820856 · Received November 10, 2004

    Report

    Report Number
    1217052-2004-00087
    Event Type
    Malfunction
    Date Received
    November 10, 2004
    Date of Event
    October 26, 2004
    Report Date
    October 27, 2004
    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

    RESULTS EVALUATION: SMITHS MEDICAL ASD, INC. IS UNABLE TO FULLY EVALUATE THIS REPORT AS THERE WAS NO SAMPLE FOR EVALUATION. THE USER FACILITY GAVE ONE DEVICE MANUFACTURING LOT AS A POSSIBLE LOT NUMBER. REVIEW OF THE RELATED MANUFACTURING RECORDS SHOW NO PROBLEMS NOTED. REVIEW OF COMPLAINTS DATABASE SHOW NO SIMILAR REPORTS ON THE POSSIBLE LOT NUMBERS OF NEEDLE USED IN THE POSSIBLE FINISHED GOOD LOT NUMBER. TERUMO MEDICAL COPR IS THE SUPPLIER OF THIS NEEDLE. THEY HAVE BEEN NOTIFIED OF THIS EVENT. FURTHER EVALUATION WILL NOT BE POSSIBLE WITHOUT THE ACTUAL EVENT SAMPLE.

    Description of Event or Problem · 1

    USER ALLEGES THEY HAD ONE EVENT OF THE NEEDLE BECOMING DISENGAGED FROM THE HUB, LEAVING 1/4" OR SO OF THE CREAM COLORED EPOXY EXPOSED OUT OF THE PATIENT DELTOID MUSCLE. THE CLINICIAN PULLED THE NEEDLE FROM THE PATIENT AND DISPOSED OF IN A SHARPS CONTAINER. NO INJURY TO CLINICIAN OR PATIENT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR