BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB

    MDR report key: 9146696 · Received October 2, 2019

    Report

    Report Number
    8041187-2019-00782
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    September 17, 2019
    Report Date
    October 9, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057819
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE REPRESENTATIVE SAMPLE WAS RECEIVED FOR INVESTIGATION. THE ONE REPRESENTATIVE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION. THERE WERE NO DEFORMATION/DAMAGE OBSERVED ON THE ECLIPSE HUB AND SAFETY SHIELD. NO BREAKAGE OBSERVED ON THE SAFETY LOCK PIN. THE REPRESENTATIVE SAMPLE WAS SUBJECTED TO THE ECLIPSE SAFETY SHIELD INSPECTION TO CHECK FOR HUB HOOK BREAKAGE OR SAFETY SHIELD FALL OFF / BREAK OFF. THE SAMPLE PASSED THE INSPECTION ACTIVATION / LOCKING FORCE :THE REPRESENTATIVE SAMPLE WAS ACTIVATED PER TEST METHOD PROCEDURE, IT377. THE ACTIVATION FORCE RESULTS MET THE SPECIFICATION REQUIREMENTS UNABLE TO CONFIRM THE CUSTOMER EXPERIENCE AS SAMPLE PASSED THE INSPECTION. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB HAS BEEN FOUND EXPERIENCING SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE HEALTH CARE PROVIDER RECEIVED A NEEDLE STICK INJURY AFTER THE SAFETY SHIELD BROKE OFF. VERBATIM: ISSUE WITH 3ML 25G 5/8¿ BD ECLIPSE NEEDLES. ONE OF OUR STAFF HAD A NEEDLE STICK INJURY WHEN ACTIVATING THE SAFETY SHIELD. THE SAFETY SHIELD WENT SIDEWAYS WHEN PUSHED AND BROKE OFF CAUSING THE NURSE¿S THUMB TO SCRAPE ACROSS THE USED NEEDLE. DEFECTIVE PRODUCT WAS NOT RETAINED.

    Additional Manufacturer Narrative · 1

    PMA/510K: K980987 / K161170. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB HAS BEEN FOUND EXPERIENCING SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE HEALTH CARE PROVIDER RECEIVED A NEEDLE STICK INJURY AFTER THE SAFETY SHIELD BROKE OFF. VERBATIM: ISSUE WITH 3ML 25G 5/8¿ BD ECLIPSE NEEDLES. ONE OF OUR STAFF HAD A NEEDLE STICK INJURY WHEN ACTIVATING THE SAFETY SHIELD. THE SAFETY SHIELD WENT SIDEWAYS WHEN PUSHED AND BROKE OFF CAUSING THE NURSE¿S THUMB TO SCRAPE ACROSS THE USED NEEDLE. DEFECTIVE PRODUCT WAS NOT RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942528 SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 7326076 30382903057819

    Patients

    Seq Age Sex Outcome Treatment
    1 Other