BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE NEEDLE

    MDR report key: 12052713 · Received June 23, 2021

    Report

    Report Number
    8041187-2021-00522
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 17, 2021
    Report Date
    July 30, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057871
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL?: YES. D10: RETURNED TO MANUFACTURER ON: 6/21/2021. H6: INVESTIGATION: ONE PHOTO, THREE SAMPLES WITHOUT PACKAGING, AND ONE EMPTY UNIT PACKAGE WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE TEAM WAS UNABLE TO OBSERVE THE CRACKED BARREL DEFECT AS ONLY THE TOP WEB PACKAGING WAS PROVIDED. THE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION TO CHECK FOR A CRACKED BARREL. ONE CRACK LINE WAS OBSERVED ON THE SURFACE ON THE SURFACE OF THE SYRINGE BARREL FOR ALL THREE RETURNED SAMPLES. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. THE SYRINGE MANUFACTURING PROCESS WAS REVIEWED. THE CRACK LINE ON THE BARREL COULD HAVE OCCURRED AT THE ASSEMBLY MACHINE. AT THIS MACHINE, THERE IS A ROTARY MAIN ASSEMBLY DIAL DURING THE TRANSFER OF THE SYRINGE PRODUCT TO THE EXERCISER DIAL, THE SYRINGE MAY TILT AND HIT AGAINST THE DIAL SIDE GUIDE RESULTING IN A PART BEING TRAPPED OR JAMMED. WHEN THERE IS A PRODUCT TRAPPED OR JAMMED AT THE SIDE GUIDE, IT RESULTS IN THE SUBSEQUENT SYRINGE TO RUB AGAINST THE JAMMED PRODUCT WHICH CAUSED CRACKED ON THE BARREL BODY. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:305787; BATCH NO: 9234610. CRACKS ON BD 3 ML SYRINGES, NORMAL SALINE LEAKING ON FROM CRACKS. CRACK NOTED FROM 0.5ML-2.0 ML MARKINGS ON ONE SYRINGE. CRACK NOTED FROM 0.2ML MARKING -1.4ML MARKING. CRACK NOTED FROM 0.5ML MARKING -1.5ML MARKING.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:305787, BATCH NO: 9234610. CRACKS ON BD 3 ML SYRINGES, NORMAL SALINE LEAKING ON FROM CRACKS. CRACK NOTED FROM 0.5ML-2.0 ML MARKINGS ON ONE SYRINGE. CRACK NOTED FROM 0.2ML MARKING -1.4ML MARKING. CRACK NOTED FROM 0.5ML MARKING -1.5ML MARKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951660 BD ECLIPSE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305787 9234610 30382903057871

    Patients

    Seq Age Sex Outcome Treatment
    1