BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 22883243 · Received August 25, 2025

    Report

    Report Number
    1911916-2025-00606
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    August 12, 2025
    Report Date
    August 28, 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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT WAS REPORTED THE FILTER NEEDLE WAS FAULTY, CAUSING MEDICATION TO LEAK DURING WITHDRAWAL FROM THE VIAL. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 305211 AND LOT NUMBER 4031348. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE DEFECT, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. SHOULD YOU ENCOUNTER ANY FURTHER ISSUES WITH OUR PRODUCT, WE WOULD APPRECIATE THE OPPORTUNITY TO PERFORM A DETAILED ANALYSIS. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 0

    IT IS REPORTED FAULTY NEEDLE FILTER CAUSING LEAK. EVENT DESCRIPTION: MATERIAL # 305211, BATCH # 4031348. ON 15JUL2025 WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE CI ¿ BROKEN FILTER NEEDLE THE OFFICE STAFF REPORTED THE FOLLOWING: ¿THE FILTER NEEDLE WAS FAULTY. THE MEDICATION WAS LEAKING FROM THE FILTER NEEDLE DURING THE WITHDRAWAL OF THE MEDICATION FROM THE VIAL, THUS THERE WAS NOT ENOUGH MEDICATION TO RETRIEVE THE FULL DOSE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335385 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