BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 22861860 · Received August 21, 2025

    Report

    Report Number
    1911916-2025-00596
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    April 2, 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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT WAS REPORTED THE FILTER NEEDLE WAS PLACED ON THE SYRINGE AND THE MEDICATION WAS BEING WITHDRAWN, THE MEDICATION LEAKED OUT. 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 LEAKAGE. EVENT DESCRIPTION: ON 09APR2025 WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE CI, LEAKER SYRINGE W/ HUB. ON (B)(6) 2025, THE OFFICE STAFF REPORTED THE FOLLOWING: ¿WHEN THE FILTER NEEDLE WAS PLACED ON THE SYRINGE AND THE MEDICATION WAS BEING WITHDRAWN, THE MEDICATION LEAKED OUT. IT LEAKED THE LUER-LOCK CONNECTION BETWEEN THE FILTER NEEDLE AND THE SYRINGE. THE DOCTOR CONFIRMED THE FILTER NEEDLE WAS ATTACHED TIGHTLY TO THE SYRINGE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443320 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