BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ECLIPSE¿ NEEDLE WITH SMARTSLIP¿ TECHNOLOGY

    MDR report key: 5606445 · Received April 25, 2016

    Report

    Report Number
    3002682307-2016-00008
    Event Type
    Injury
    Date Received
    April 25, 2016
    Date of Event
    April 21, 2016
    Report Date
    May 27, 2016
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE U.S. AND NOT SOLD IN THE U.S. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: SEPTEMBER, 2014.

    Additional Manufacturer Narrative · 1

    RESULTS: ONE UNUSED SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED NO DAMAGE AND THE SAFETY SHIELD WAS CORRECTLY ASSEMBLED INTO THE HUB. FUNCTIONALITY TESTS WERE CARRIED OUT WITH CORRECT RESULTS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 1409002. A QUALITY NOTIFICATION REVIEW REVEALED NO QNS DETECTED FOR BROKEN SAFETY SHIELDS, HOWEVER, THERE WERE TWO QNS GENERATED FOR BURNT RESIN, ONE QN FOR FLASHES, AND ONE QN FOR FLASHES IN PIVOT. CONCLUSION: 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. ADDITIONALLY, OUR QUALITY ENGINEER NOTES THAT ALTHOUGH THE QNS GENERATED WOULD NOT AFFECT THE FUNCTIONALITY OF THE DEVICE. IT IS POSSIBLE THAT THIS ISSUE COULD BE RELATED WITH SOME UNEXPECTED TEMPORARY MECHANICAL FAILURE IN THE REJECTION SYSTEM OF SAFETY SHIELD ASSEMBLED MACHINE WHERE THE SAFETY SHIELD COULD BE NOT BE CORRECTLY ASSEMBLED OR DAMAGED AND THE DETECTION DID NOT REJECT IT. THE ASSEMBLY PROCESS HAS A SYSTEM THAT INSPECTS 100% THE PROPERLY OPENING AND ACTIVATION OF SAFETY SHIELD OF NEEDLES, REJECTING THE DEFECTIVE ONES. BASED ON THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING INSPECTION, WE ARE CERTAIN THAT THE PROBABILITY OF OCCURRENCE OF THIS NONCONFORMANCE IS VERY LOW AND ALWAYS, IN SPORADIC CASES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A NURSE HAD GIVEN AN INTRAMUSCULAR INJECTION WITH A BD ECLIPSE¿ NEEDLE WITH SMARTSLIP¿ TECHNOLOGY, THE SAFETY DEVICE DID NOT WORK AND THE NURSE OBTAINED A CONTAMINATED NEEDLE STICK INJURY TO HIS/HER LEFT FOREFINGER. THE NURSE RECEIVED POST EXPOSURE LAB WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260013 BD ECLIPSE¿ NEEDLE WITH SMARTSLIP¿ TECHNOLOGY HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 1409002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention