BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 23139772 · Received September 24, 2025

    Report

    Report Number
    1911916-2025-00657
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 12, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    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

    IT WAS REPORTED THE NEEDLE WAS BROKEN IN SOME WAY, SO THE MEDICATION WAS LEAKING THROUGH THE FILTER NEEDLE. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 305211 AND LOT NUMBER 4051928. 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. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY. COMPLAINTS RELATED TO THIS DEVICE AND THE REPORTED CONDITION WILL CONTINUE TO BE MONITORED AND ANALYZED FOR EMERGING TRENDS BY OUR QUALITY TEAM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE FILTER BLUNT FILL 18X1-1/2 WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305211 LOT # 4051928   VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ON 07AUG2025 XXX WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE CI ¿ BROKEN FILTER NEEDLE. ON 07AUG2025, THE OFFICE STAFF REPORTED THE FOLLOWING: ¿ THE FILTER NEEDLE WAS "FAULTY¿. THE FILTER NEEDLE "WAS BROKEN IN SOME WAY SO THE MEDICATION WAS LEAKING THROUGH THE FILTER NEEDLE" WHILE THE DOSE WAS BEING WITHDRAWN FROM THE VIAL.¿ CATALOG: 305211 LOT: 4051928. ADDITIONAL INFORMATION PROVIDED: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? 07AUG2025 2.ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. N/A. 3.CAN YOU SHARE ANY PHYSICAL SAMPLE OR PHOTO IF AVAILABLE FOR INVESTIGATION? NO SAMPLE/PHOTO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2431946 BD NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 4051928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown