BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 22394437 · Received July 3, 2025

    Report

    Report Number
    1911916-2025-00478
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    April 28, 2025
    Report Date
    July 3, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    00382903052110
    PMA / PMN Number
    K941562
    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 A REPORT WAS RECEIVED INDICATING THAT A FRAGMENT OF THE RUBBER STOPPER DETACHED AND PASSED THROUGH THE FILTER NEEDLE INTO THE SYRINGE. AS NO PHYSICAL SAMPLE WAS RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, TWELVE PHOTOGRAPHS WERE SUBMITTED FOR REVIEW BY OUR QUALITY TEAM. THE IMAGES DEPICT A NEEDLE ASSEMBLY WITHOUT A PLASTIC SHIELD, INCLUDING THE NEEDLE TIP AND FILTER HUB. TWO OF THE PHOTOGRAPHS APPEAR TO BE SCHEMATIC REPRESENTATIONS OF A NEEDLE HUB WITH A FILTER. NO ADDITIONAL INSIGHTS COULD BE DERIVED FROM THE PHOTOGRAPHS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE PROVIDED MATERIAL NUMBER 305211, LOT 4031348. THE REVIEW FOUND NO QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. ADDITIONALLY, NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE PHOTOGRAPHIC EVIDENCE, THE REPORTED ISSUE COULD NOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A PIECE OF THE RUBBER STOPPER CAME OFF AND CAME THROUGH THE FILTER NEEDLE INTO THE SYRINGE. MATERIAL#: 305211 BATCH#: 4031348 ON (B)(6) 2025, THE HCP REPORTED, ¿DURING WITHDRAWAL OF THE EYLEA HD DOSE FROM THE VIAL, A PIECE OF THE RUBBER STOPPER CAME OFF AND CAME THROUGH THE FILTER NEEDLE INTO THE SYRINGE.¿ ADDITIONAL INFO: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. N/A CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 28APR2025 TOTAL NUMBER OF OCCURRENCES? ONE OCCURRENCE PER THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176976 NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4031348 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown