BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE NEEDLE

    MDR report key: 11916394 · Received June 1, 2021

    Report

    Report Number
    8041187-2021-00450
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    April 26, 2021
    Report Date
    June 4, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA/NEEDLE/SYRINGE OR OTHER FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305787 BATCH NO: 9333914 WE WERE FILLING THESE NEEDLES AND WHEN WE PULL BACK THE RUBBER THERE IS A BIT A MOISTURE. WE ARE UNSURE WHETHER THIS IS STERILE OR SAFE TO USE SO WE DISCARDED THEM.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: AN ADDITIONAL PMA/510(K) APPLIED TO THE NEEDLE PORTION OF THE DEVICE AS K161170 A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA/NEEDLE/SYRINGE OR OTHER FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305787, BATCH NO: 9333914. WE WERE FILLING THESE NEEDLES AND WHEN WE PULL BACK THE RUBBER THERE IS A BIT A MOISTURE. WE ARE UNSURE WHETHER THIS IS STERILE OR SAFE TO USE SO WE DISCARDED THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809472 BD ECLIPSE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 9333914

    Patients

    Seq Age Sex Outcome Treatment
    1