BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROLANCE

    MDR report key: 23866485 · Received December 22, 2025

    Report

    Report Number
    3002682307-2025-00145
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 3, 2025
    Report Date
    March 11, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903013005
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301300 AND LOT NUMBER 220814. 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) PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURE, A DROP OF LIQUID WAS OBSERVED ON THE HUB COMPONENT WHICH IS UNDERSTOOD AS BEING CAUSED BY LEAKAGE. TWENTY (20) RETAINED SAMPLES OF THE REPORTED LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THE RETAINED NEEDLE SAMPLES WERE ASSEMBLED WITH A BD DISCARDIT 2ML SYRINGE. NO SIGNS OF DEFECTIVE HUB CONNECTION OR LEAKAGE WERE OBSERVED. ALTHOUGH LEAKAGE WAS OBSERVED THROUGH THE PICTURE SAMPLE, AN EXACT CAUSE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION RESULTS. DURING THE MOLDING PROCESS, MOLTEN PLASTIC IS INJECTED AT VERY HIGH TEMPERATURES TO FILL THE MOLD CAVITY AND FORM THE HUB COMPONENT. WHEN THE PLASTIC COOLS BETWEEN MOLDING CYCLES, A VERY SMALL SOLIDIFIED PLASTIC PARTICLE¿KNOWN AS A ¿COLD DROP¿¿MAY REMAIN AT THE INJECTION POINT OF THE MOLD. DURING THE NEXT MOLDING CYCLE, THIS PARTICLE IS INJECTED TOGETHER WITH THE MOLTEN PLASTIC AND BECOMES MIXED INTO THE MATERIAL FORMING THE HUB. THIS PHENOMENON IS INHERENT TO ANY MOLDING PROCESS AND SHOULD NOT POSE ANY ISSUE FOR THE PRODUCT. HOWEVER, IN SOME VERY ISOLATED CASES, THIS ¿COLD DROP¿ MAY REMAIN VERY CLOSE TO THE INJECTION POINT, CREATING A SMALL CRACK IN THE HUB THAT CAN LEAD TO LEAKAGE. OUR MOLDS ARE DESIGNED TO MINIMIZE AND PREVENT THIS ISSUE, AND THE LIKELIHOOD OF ENCOUNTERING THE REPORTED NONCONFORMANCE IS EXTREMELY LOW AND ONLY ON A VERY ISOLATED BASIS. IF THIS ISSUE WERE TO REOCCUR, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THE AFFECTED PHYSICAL SAMPLE(S). 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

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 ABBOTT HAS RECEIVED COMPLAINT FROM A CLIENT REGARDING A LEAKING BD RECONSTITUTION (MIXING) NEEDLE. THE LEAK OCCURS AT THE POINT WHERE THE NEEDLE TUBE IS BONDED INTO THE HUB. PLEASE NOTE THAT THIS NOTIFICATION IS FOR AWARENESS AND TRENDING PURPOSES ONLY AND DOES NOT CONSTITUTE AN OFFICIAL COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144258 MICROLANCE NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 220814 00382903013005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown