BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVENTIONAL NEEDLES

    MDR report key: 23158882 · Received September 26, 2025

    Report

    Report Number
    3002682307-2025-00114
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    August 12, 2025
    Report Date
    November 20, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 303262 AND LOT NUMBER 250307. 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, THE AFFECTED PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, ADDITIONAL WHITE DROPS OF EPOXY (THE GLUE USED TO BOND THE CANNULA TO THE HUB) WERE OBSERVED ON THE CANNULA COMPONENT. THIS ISSUE LIKELY OCCURRED DURING THE ASSEMBLY PROCESS, SPECIFICALLY AT THE STAGE WHERE EPOXY IS DISPENSED INTO THE HUB. IT MAY HAVE BEEN CAUSED BY A TEMPORARY STOPPAGE OR A MALFUNCTION IN THE EPOXY DISPENSING EQUIPMENT. AS A RESULT, AN EXCESSIVE AMOUNT OF EPOXY WAS APPLIED, WHICH THEN OVERFLOWED ONTO THE SUBSEQUENT CANNULA, LEADING TO THE OBSERVED DEFECT. GIVEN OUR EXPERIENCE AND SUPPORTED BY THE LOW PERCENTAGE OF DEFECTS IDENTIFIED DURING ROUTINE IN-PROCESS INSPECTIONS, THE LIKELIHOOD OF THIS TYPE OF NON-CONFORMANCE OCCURRING IS CONSIDERED TO BE VERY LOW. 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

    THE NEEDLE HAS NOT BEEN USED AND HAS NOT BEEN OPENED BECAUSE IT HAS A WHITE PLAQUE AT THE END.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317030 CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 250307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown