BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE

    MDR report key: 5998369 · Received October 4, 2016

    Report

    Report Number
    8041187-2016-00057
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    September 6, 2016
    Report Date
    November 8, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THREE SEALED SAMPLES WERE RETURNED FOR EVALUATION. EACH OF THE THREE UNITS WERE VISUALLY INSPECTED AND THE SAFETY SHIELDS WERE ACTIVATED AS OUTLINED BY THE IFU. THERE WERE NO OBSERVATIONS MADE OR ISSUES ENCOUNTERED DURING THE INVESTIGATION. AS PREVIOUSLY REPORTED, A REVIEW OF THE DEVICE HISTORY RECORD AND MANUFACTURING RECORD REVEALED NO IRREGULARITIES. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S REPORTED FAILURE MODE. IT WAS PREVIOUSLY REPORTED THAT CAPA (B)(4) HAD BEEN INITIATED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. AFTER THE CONCLUSION OF THE INVESTIGATION ACTIVITIES AT THIS SITE THERE WAS NO MANUFACTURING ROOT CAUSE THAT COULD BE IDENTIFIED. A SECOND CAPA, (B)(4), HAS BEEN OPENED TO INVESTIGATE WHETHER THE REPORTED FAILURE MODE IS DUE TO A DESIGN RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS AVAILABLE FOR EVALUATION, HOWEVER THE MANUFACTURING SITE HAS COMPLETED A NO SAMPLE INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5231205. A MANUFACTURING REVIEW REVEALED THAT PREVENTATIVE MAINTENANCE, CALIBRATION AND EQUIPMENT HAD NO INFLUENCE OF THE REPORTED DEFECT. CONCLUSION: A CONCLUSION IS NOT YET AVAILABLE AS THE EVALUATION IS STILL IN PROGRESS. HOWEVER, CAPA (B)(4) HAS BEEN INITIATED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE GAVE TWO VACCINATIONS WITH 25 G X 5/8 IN. BD ECLIPSE NEEDLES. THE NURSE THOUGHT THAT SHE HAD SNAPPED THE PINK SAFETY SHIELD INTO PLACE AFTER ADMINISTERING AND PLACED THE NEEDLES ON THE COUNTER. WHEN SHE PICKED UP THE NEEDLES SHE OBTAINED A CONTAMINATED NEEDLE STICK INJURY. THE NURSE RECEIVED POST EXPOSURE LAB WORK. THE RESULTS OF THE TESTS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650276 25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5231205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention