BEUDAMED
    FDA Adverse Event Injury Summary report: N

    23 G X 1 IN. BD ECLIPSE¿ HYPODERMIC NEEDLE

    MDR report key: 6037495 · Received October 18, 2016

    Report

    Report Number
    8041187-2016-00069
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    June 19, 2016
    Report Date
    January 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5106261. A REVIEW OF PREVENTIVE MAINTENANCE, CALIBRATION, AND EQUIPMENT REVEALED NO ABNORMALITY THAT COULD HAVE INFLUENCED THE ISSUE. CONCLUSIONS - AS THERE WAS NO ACTUAL RETURNED SAMPLE FOR EVALUATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. OF NOTE, CAPA (B)(4) HAS BEEN OPENED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - THE BD COMPLAINTS LAB RECEIVED ONE DISENGAGED PINK SAFETY SHIELD ONLY. IT WAS VISUALLY INSPECTED AND NO ISSUES WERE OBSERVED ON THE RETURNED COMPONENT. THE SAFETY SHIELD WAS EVALUATED BY THE MANUFACTURING SITE AND REPORTED THE SAME FINDINGS. CONCLUSION - BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. THE RESULTS OF PREVIOUS INVESTIGATIONS CONFIRM THE REPORTED ISSUE OF ECLIPSE COMPLAINTS REGARDING SAFETY MECHANISM BREAKAGE. HOWEVER, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT WAS NOT DETERMINED. OF NOTE, CAPA (B)(4) (REPORTED ON INITIAL MDR) HAVE BEEN OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES FOR THE SAFETY SHIELD DISENGAGEMENT FROM THE ECLIPSE NEEDLE. SITUATION ANALYSIS MSS-16-837-SA HAS BEEN OPENED AND AN URGENT PRODUCT ADVISORY NOTICE HAS BEEN RELEASED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUSPECT DEVICE WAS BEING PLACED IN THE SHARPS CONTAINER AFTER ENGAGING THE SAFETY FEATURE. THE END OF THE SAFETY WAS BROKEN, LEAVING THE NEEDLE EXPOSED, AND THERE WAS A REPORT OF A BLOOD OR BODY FLUID EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688993 23 G X 1 IN. BD ECLIPSE¿ HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5106261

    Patients

    Seq Age Sex Outcome Treatment
    1 Other