BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE NEEDLE

    MDR report key: 10243051 · Received July 7, 2020

    Report

    Report Number
    8041187-2020-00388
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 8, 2020
    Report Date
    July 30, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057659
    PMA / PMN Number
    K161170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, SIGNS OF THE SAFETY SHIELD BEING BROKE OFF AND MISSING FROM THE UNIT PACKAGE WAS OBSERVED. THE CUSTOMER EXPERIENCE WAS CONFIRMED FROM THE PHOTO EVALUATION. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE PRIMARY PACKAGING PROCESS WAS REVIEWED. THERE IS A SAFETY SHIELD PRESENCE SENSOR TO DETECT FOR MISSING SAFETY SHIELD AND AUTO-REJECT THE PART. THE SENSOR WAS CHALLENGED AND ABLE TO AUTO-REJECT THE PART. THE SAFETY SHIELD COULD HAVE EXPERIENCED SIGNS OF BREAKAGE DURING EXERCISING MOTION AND DROPPED OFF WHEN MOVING TO THE NEXT STATION. REVIEWED THE MOLDING FIRST PIECE REPORT AND THE ROUNDNESS AND ROD OD MEASUREMENTS WERE WITHIN SPECIFICATION. ROOT CAUSE COULD NOT BE DETERMINED FOR SAFETY SHIELD BROKE OFF AS NO SAMPLE IS RETURNED FOR INVESTIGATION. THERE IS A VISION SYSTEM AT THE PRIMARY PACKAGING MACHINE TO CHECK FOR MISSING SAFETY SHIELD. UPON DETECTED MISSING SHIELD, THE VISION SYSTEM WILL TRIGGER THE MACHINE TO STOP. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE SAFETY SHIELD WAS FOUND DETACHED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE CONTINUE TO FIND UNACCEPTABLE UNITS (MISSING SAFETY SHIELD) IN LOT NUMBER 8171369."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE SAFETY SHIELD WAS FOUND DETACHED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE CONTINUE TO FIND UNACCEPTABLE UNITS (MISSING SAFETY SHIELD) IN LOT NUMBER 8171369."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707104 BD ECLIPSE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305765 8171369 30382903057659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other