BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVENTIONAL NEEDLES

    MDR report key: 23903405 · Received December 28, 2025

    Report

    Report Number
    3002682307-2025-00149
    Event Type
    Malfunction
    Date Received
    December 28, 2025
    Date of Event
    December 17, 2025
    Report Date
    May 5, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    UNK
    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 304000 AND LOT NUMBER 250608. 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, THREE (3) SHELF CARTONS OF UNUSED NEEDLE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SHELF CARTONS WERE FROM LOTS 240512, 250608, 250802. THE SHELF CARTONS CONTAINED 59 UNUSED NEEDLES FOR LOT 250802, 61 UNUSED NEEDLES FOR LOT 250608, AND 43 UNUSED NEEDLES FOR LOT 240512. THE SAMPLES WERE EVALUATED, CHECKING BOTH THE BEVEL GEOMETRY AND THE PRESENCE OF ANY OBSTRUCTION. ALL OF THE SAMPLES SHOWED A CORRECT SHAPE AND NO SIGNS OF CLOGGING OR ANY RELATED ISSUES WERE DETECTED. BASED ON THE INVESTIGATION RESULTS, A CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT. THE ASSEMBLY PROCESS INSPECTS ALL NEEDLES USING A CAMERA SYSTEM. THE CAMERA SENSES A LIGHT SOURCE WHICH IS POSITIONED AT THE OPPOSITE END OF THE NEEDLE. IF THE CAMERA DOES NOT SENSE THE LIGHT SOURCE, AN OCCLUSION CONDITION MAY BE PRESENT AND AS A RESULT, THE NEEDLE IS AUTOMATICALLY REJECTED. THE CAMERA SYSTEM IS CHALLENGED EVERY EIGHT (8) HOURS OF PRODUCTION. NEEDLES ARE ALSO ROUTINELY INSPECTED FOR OCCLUSION AS PART OF AN IN-PROCESS INSPECTION AFTER ASSEMBLY. 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

    DOCTORS INDICATE THAT AT LEAST TWO BATCHES ARE NOT GOOD, THE NEEDLES GIVE RESISTANCE WHEN INJECTING PLUS THEY LEAK. RESPONSE RECEIVED ON: (B)(6) 2025 1:33 PM - THE COMPLAINTS WERE OBSERVED DURING USE IN SEVERAL PATIENTS BY VARIOUS NEUROLOGISTS. THEY EXPERIENCED SIGNIFICANT RESISTANCE TO THE BOTULINUM TOXIN INJECTION, AND FLUID LEAKED. - AS FAR AS I KNOW, THE PATIENTS EXPERIENCED NO DISCOMFORT, BUT IT COULD HAVE HAD SERIOUS CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575844 CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 250608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown