BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 23366297 · Received October 23, 2025

    Report

    Report Number
    1911916-2025-00694
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    July 17, 2025
    Report Date
    October 24, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052110
    PMA / PMN Number
    NA
    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

    (B)(4) FOLLOW UP. A GRAY SUBSTANCE WAS REPORTED FLOATING IN THE MEDICATION. AS NO PHYSICAL SAMPLE WAS RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, FOUR PHOTOGRAPHS AND TWO COMPARATIVE CHARTS WERE SUBMITTED FOR REVIEW BY THE QUALITY TEAM. TWO OF THE PHOTOGRAPHS DEPICT THE TOP AND BOTTOM SIDES OF A VIAL STOPPER, WHILE THE REMAINING TWO SHOW THE FOREIGN MATERIAL UNDER MAGNIFICATION. THE CHARTS PROVIDE A COMPARISON BETWEEN THE FOREIGN MATTER AND THE RUBBER STOPPER MATERIAL. HOWEVER, THE ANALYSIS WAS INCONCLUSIVE, AS NO DEFINITIVE MATCH PERCENTAGE WAS ESTABLISHED. NO ADDITIONAL INSIGHTS COULD BE DRAWN FROM THE INFORMATION PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR MATERIAL NUMBER 305211, LOT 4031348. THE ASSESSMENT DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND PHOTOGRAPHIC EVIDENCE, THE REPORTED SYMPTOM HAS BEEN CONFIRMED. IN THE ABSENCE OF A PHYSICAL SAMPLE, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE FILTER BLUNT FILL 18X1-1/2 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305211 BATCH#: 4031348. RCC RECEIVED A COMPLAINT VIA EMAIL. ON 17JUL2025 REGENERON WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE CI ¿ BENT INJECTION NEEDLE. ON (B)(6) 2025, THE OFFICE STAFF REPORTED THE FOLLOWING: ¿THERE WAS ¿A GRAY SUBSTANCE FLOATING IN THE MEDICATION.¿ THIS OCCURRED ON (B)(6) 2025. THE SUBSTANCE WAS SEEN WHILE THE NEEDLE WAS BEING PRIMED AFTER THE MEDICATION HAD BEEN WITHDRAWN FROM THE VIAL INTO THE SYRINGE. REPORTER COULD NOT DESCRIBE THE SIZE OR SHAPE. SHE SAID THE GRAY COLOR WAS ¿A LITTLE BIT LIGHTER THAN THE SEAL ON TOP OF THE VIAL.¿ REGENERON LDP LOT: 8463800028. FILTER NEEDLE: CATALOG: 305211 LOT: 4031348. ADDITIONAL INFORMATION PROVIDED: IN THE PRIOR EMAIL I EXPLAIN THAT THE DEFECT CODE FOR BENT INJECTION NEEDLE IS INCORRECT AND THAT THE CORRECT DEFECT IS FOREIGN MATTER AS DESCRIBED IN THE NARRATIVE. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT FOR BOTH EVENT IN FORMAT DD-MMM-YYYY? 17JUL2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2738896 BD NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 4031348 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown