BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE

    MDR report key: 6183272 · Received December 16, 2016

    Report

    Report Number
    8041187-2016-00092
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    October 14, 2016
    Report Date
    January 9, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 # 5323084. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE REPORTED FAILURE MODE. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. HOWEVER, CAPAS (B)(4) WERE INITIATED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: ALTHOUGH IT WAS INITIALLY REPORTED THAT THE CUSTOMER DID NOT HAVE SAMPLES AVAILABLE FOR EVALUATION, 100 SEALED SAMPLES WERE RETURNED FOR INVESTIGATION. A SIMULATED USE TEST OF 30 RANDOMLY SELECTED SAMPLES WAS PERFORMED BY ACTIVATING THE SAFETY MECHANISM ACCORDING TO THE IFU. NO SAFETY MECHANISMS BROKE OFF DURING ACTIVATION. AS PREVIOUSLY REPORTED, THERE WERE NO IRREGULARITIES FOUND DURING THE DEVICE HISTORY RECORD OR MANUFACTURING RECORD REVIEWS. CONCLUSION: AS PREVIOUSLY REPORTED, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT HAS NOT BE DETERMINED. IN ADDITION TO CAPAS (B)(4) PREVIOUSLY INDICATED IN THE INITIAL MDR, THIS PRODUCT HAS A FIELD ACTION NOTIFICATION #: MSS-16-837-FA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER GIVING A FLU VACCINE WITH A 25 G X 5/8 IN. BD ECLIPSE NEEDLE, A CLINICIAN ENGAGED THE SAFETY MECHANISM AND IT BROKE OFF OF THE NEEDLE. THIS RESULTED IN A CONTAMINATED NEEDLE STICK INJURY. BOTH THE SOURCE PATIENT AND CLINICIAN RECEIVED POST EXPOSURE LAB WORK. THE TEST RESULTS WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834338 25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5323084

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention