BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVENTIONAL NEEDLES

    MDR report key: 23390567 · Received October 27, 2025

    Report

    Report Number
    3002682307-2025-00124
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 3, 2025
    Report Date
    May 4, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301000 AND LOT NUMBER 220921. 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 AT THIS TIME. IT IS UNDERSTOOD THAT THE PICTURE ALIGNS TO ONE (1) OF THE REPORTED EVENTS RELATED TO THIS INCIDENT. THE REFERENCE PICTURE FOR THE RELATED EVENT WAS USED AS REFERENCE FOR THE INVESTIGATION OF ALL EVENTS IN THIS RECORD. THROUGH EXAMINATION OF THE PICTURE SAMPLE, THE NEEDLE HUB COMPONENT SEEMS TO HAVE BEEN SUBJECTED TO A TORSION MOVEMENT THAT EVOKED A DEFECT WHICH WOULD CONSEQUENTLY CAUSE LEAKAGE. FROM THE PICTURE SAMPLE, IT IS UNDERSTOOD THAT THIS DEFECT TOOK PLACE DURING THE HANDLING OF THE PRODUCT. FROM THE ONE (1) PICTURE, THE DEFECT OF BENT NEEDLE COULD NOT BE OBSERVED. BASED ON THE INVESTIGATION RESULTS, A CAUSE RELATED TO THE NEEDLE MANUFACTURING CANNOT BE DETERMINED AT THIS TIME. FROM THE SAMPLE EXAMINATION, IT IS BELIEVED THAT THE DAMAGE TOOK PLACE DURING USE, AND THEREFORE, THE NEEDLE WAS NOT DAMAGED BEFORE USE. WE CANNOT EXCLUDE THE POSSIBILITY OF HANDLING AS A CAUSE IN THIS INCIDENT OR INCOMPATIBILITIES BETWEEN THE DEVICES USED. 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.

    Description of Event or Problem · 0

    I WANTED TO COME BACK TO CLARIFY THE LOCATION WHERE THE LEAKS OCCURRED, THE LEAK WAS AT THE CONNECTION OF THE NEEDLE TO THE PLASTIC HOUSING, NOT THE CONNECTION TO THE FILER. LEAK OCCURRED ON (B)(6) 2025. LEAKS OCCURRED IN THE SAME LOCATION WHICH IS THE CONNECTION BETWEEN THE FILTER AND THE MICROLANCE. WAS THE DEVICE BEING USED IN/ON PATIENT WHEN THE ISSUE OCCURRED? NOT USED ON PATIENT, THIS HAPPENED DURING MANUFACTURING WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN, NO. IF LEAKAGE OCCURRED, PLEASE CONFIRM THE FLUID THAT LEAKED. MOTHER SOLUTION, WHEN TRANSFERRING TO THE VIAL. COULD YOU PLEASE CONFIRM WHETHER A BENT NEEDLE WAS OBSERVED IN THE THIRD CASE THAT OCCURRED ON (B)(6) 2025, OR IF IT WAS ONLY A LEAKAGE ISSUE? CONFIRMING THIS WAS A LEAKAGE INCIDENT BETWEEN THE NEEDLE AND PLASTIC HOUSING OF NEEDLE. NO VISIBLE DEFECT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41731 CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 220921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown