BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE

    MDR report key: 6405683 · Received March 15, 2017

    Report

    Report Number
    8041187-2017-00025
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    February 22, 2017
    Report Date
    April 10, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: SAMPLES ARE AVAILABLE FOR EVALUATION BUT HAVE NOT YET BEEN RECEIVED. THE MANUFACTURING FACILITY IN (B)(4) HAS COMPLETED AN INITIAL NO SAMPLE INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5141117. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. CONCLUSION: A CONCLUSION IS NOT YET AVAILABLE AS THE EVALUATION IS STILL IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. REMEDIAL ACTION REQUIRED: CAPAS (B)(4) WERE OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. ADDITIONALLY, FIELD ACTION NOTIFICATION MSS-16-837-FA WAS INITIATED AND A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: FOUR SAMPLES; ONE USED WITHOUT PACKAGING AND THREE UNUSED IN SEALED PACKAGES, WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE USED UNIT REVEALED THAT ITS SAFETY COVER WAS DISENGAGED. ONE OF THE SEALED SAMPLES WAS ALSO EXAMINED AND ITS SAFETY COVER WAS ACTIVATED WITH NO ISSUES FOLLOWING INSTRUCTION FOR USE (IFU). NO SHIELD ACTIVATION FAILURE WAS OBSERVED AS THE NEEDLE WAS PROPERLY COVERED AND THE SAFETY COVER LOCKED IN PLACE. AS PREVIOUSLY REPORTED, NO IRREGULARITIES WERE FOUND IN THE DEVICE HISTORY RECORD OR MANUFACTURING PROCESS REVIEWS. CONCLUSION: ALTHOUGH THE USED RETURN SAMPLE REVEALED A DETACHED SAFETY SHIELD, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. REMEDIAL ACTION REQUIRED: AS PREVIOUSLY REPORTED, CAPAS (B)(4) WERE OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. ADDITIONALLY, FIELD ACTION NOTIFICATION MSS-16-837-FA WAS INITIATED AND A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY COVER OF A 18 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE BROKE OFF AS IT WAS BEING CLOSED OVER THE NEEDLE. THERE WAS NO REPORT OF INJURY OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187436 18 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5141117

    Patients

    Seq Age Sex Outcome Treatment
    1 Other