BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE

    MDR report key: 9369906 · Received November 25, 2019

    Report

    Report Number
    8041187-2019-00945
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 6, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057833
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION THERE WAS NO HUB BREAKAGE OR SAFETY SHIELD FALL OFF; THEREFORE, THE INCIDENT CAN NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON- CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE SAFETY MECHANISM DETACHED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305783, BATCH NO: 9081645. IT WAS REPORTED THAT WHEN NURSE ATTEMPTED TO ACTIVATE SAFETY MECHANISM, THE ARM DISENGAGED FROM THE HINGES AND FELL OFF. NURSE ATTEMPTED TO ACTIVATE THE SAFETY MECHANISM AND THE ARM DISENGAGED FROM THE HINGES AND FELL OFF.

    Additional Manufacturer Narrative · 1

    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 WAS REPORTED THAT BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE SAFETY MECHANISM DETACHED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305783, BATCH NO: 9081645. IT WAS REPORTED THAT WHEN NURSE ATTEMPTED TO ACTIVATE SAFETY MECHANISM, THE ARM DISENGAGED FROM THE HINGES AND FELL OFF. NURSE ATTEMPTED TO ACTIVATE THE SAFETY MECHANISM AND THE ARM DISENGAGED FROM THE HINGES AND FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168271 BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 9081645 30382903057833

    Patients

    Seq Age Sex Outcome Treatment
    1 Other