BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE SMARTSLIP

    MDR report key: 22777955 · Received August 11, 2025

    Report

    Report Number
    3002682307-2025-00099
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 24, 2025
    Report Date
    November 17, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903057603
    PMA / PMN Number
    K100209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305760 AND LOT NUMBER 2011006. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PHYSICAL SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, IT WAS OBSERVED THAT THE SNAP CLIP WAS ACTIVATED. BASED ON THE SAMPLE RESULTS, NO MANUFACTURING RELATED DEFECTS WERE IDENTIFIED, AND AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED ISSUE. IT IS POSSIBLE THAT THE HANDLING OF THE PRODUCT HAD AN IMPLICATION IN THE REPORTED EVENT. EACH LOT MANUFACTURED IS TESTED PRIOR TO RELEASE FOR FINAL SAFETY SHIELD ACTIVATION TESTING (THE FORCE REQUIRED TO ACTIVATE THE ECLIPSE HYPODERMIC SAFETY NEEDLE PRODUCT). LOT NUMBER 2011006 WAS RELEASED IN COMPLIANCE WITH SPECIFICATIONS. THE ASSEMBLY PROCESS HAS A SYSTEM THAT INSPECTS ALL NEEDLES FOR PROPER OPENING AND ACTIVATION OF THE SAFETY SHIELD, REJECTING ANY DEFECTIVE PRODUCT IDENTIFIED. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THE PROBABILITY OF THIS DEFECT IS VERY LOW WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE ECLIPSE SAFETY SHIELD BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DESIGN OF THESE NEEDLES IS VERY POOR QUALITY. THEY REQUIRE A GREAT DEAL OF FORCE TO GET THE NEEDLE TO SECURE ONTO A SYRINGE WITH A LUER-LOK. I HAVE FOUND THE PINK SAFETY LOCK HAS BROKEN OFF A FEW TIMES PRIOR TO ADMINISTRATION. I HAVE HAD TO REPLACE THESE NEEDLES MULTIPLE TIMES FOR MY OWN SAFETY, TO PREVENT A NEEDLE STICK INJURY. LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT/PERSON -- DETECTED BEFORE USE OR DOES NOT TOUCH PATIENT DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034832 ECLIPSE SMARTSLIP NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 2011006 00382903057603

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown