BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 24118113 · Received January 20, 2026

    Report

    Report Number
    1911916-2026-00020
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    September 8, 2025
    Report Date
    January 12, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051069
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION IT WAS REPORTED THAT THERE WAS AN INSECURE NEEDLE SYRINGE CONNECTION. BECAUSE NO PHYSICAL SAMPLE WAS RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, THREE PHOTOGRAPHS WERE PROVIDED FOR REVIEW BY THE QUALITY TEAM. THE IMAGES SHOW A NEEDLE WITH THE PLASTIC SHIELD ASSEMBLED TO A SYRINGE, NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE PHOTOGRAPHS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305106, LOT 4081033. THE REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL IN PROCESS CONTROLS AND FINAL INSPECTIONS WERE PERFORMED PER SPECIFICATION REQUIREMENTS. BASED ON THE AVAILABLE INFORMATION, INCLUDING THE PHOTOGRAPHIC ASSESSMENT, THE REPORTED CONDITION COULD NOT BE CONFIRMED. IN THE ABSENCE OF A RETURNED SAMPLE, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT IS REPORTED CONNECTION ISSUES. VERBATIM: MATERIAL 305106 BATCH 4081033 ON 08SEP2025 REGENERON WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE CI INSECURE NEEDLE-SYRINGE CONNECTION ON 08SEP2025, THE OFFICE STAFF REPORTED THE FOLLOWING: THERE WAS A FAULTY SYRINGE FOR THE DOCTOR. WHEN HE WAS TRYING, IT WASN'T CLICKING AND IT WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181969 NEEDLE 30X1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 4081033 00382903051069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown