BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25 G X 1 IN. BD ECLIPSE¿ NEEDLE

    MDR report key: 5470341 · Received March 1, 2016

    Report

    Report Number
    8041187-2016-00012
    Event Type
    Injury
    Date Received
    March 1, 2016
    Date of Event
    February 17, 2016
    Report Date
    February 22, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5231318. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. A SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING A 25 G X 1 IN. BD ECLIPSE(TM) NEEDLE, A CLINICIAN WENT TO ACTIVATE THE DEVICE'S SAFETY MECHANISM AND IT SNAPPED OFF. THIS RESULTED IN THE CLINICIAN POKING HERSELF IN HER ARM WITH THE USED DEVICE. THE CLINICIAN RECEIVED POST EXPOSURE PROPHYLAXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128315 25 G X 1 IN. BD ECLIPSE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5231318

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention