BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 22415717 · Received July 7, 2025

    Report

    Report Number
    1911916-2025-00502
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    March 31, 2025
    Report Date
    July 24, 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

    H11 -A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, 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 FOR DEVICE EVALUATION A SMALL GREEN PARTICLE WAS OBSERVED FLOATING IN THE SOLUTION. TO SUPPORT THE INVESTIGATION, THE QUALITY TEAM RECEIVED ONE UNPACKAGED SAMPLE, A GLASS PLATE CONTAINING A PIECE OF BLUE-COLORED MATERIAL, A CHART, AND THREE PHOTOGRAPHS. A VISUAL INSPECTION OF THE SAMPLE REVEALED NO OBSERVABLE DEFECTS OR ABNORMALITIES. THE SUBMITTED PHOTOGRAPHS DEPICT A BLUE-COLORED PARTICLE WITHIN A SYRINGE. ACCORDING TO THE ACCOMPANYING CHART, THE FOREIGN MATERIAL WAS IDENTIFIED AS POLYURETHANE. NOTABLY, POLYURETHANE IS NOT UTILIZED IN THE NEEDLE ASSEMBLY MANUFACTURING PROCESS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 305211, LOT 4031348. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES OR DEVIATIONS DURING THE PRODUCTION OF THIS LOT THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. ADDITIONALLY, NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN FULL COMPLIANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE SUBMITTED SAMPLE, THE PRESENCE OF THE FOREIGN PARTICLE AS REPORTED BY THE CUSTOMER HAS BEEN CONFIRMED. HOWEVER, THE INVESTIGATION WAS UNABLE TO DETERMINE A PROBABLE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THEY NOTICED A SMALL GREEN PARTICLE FLOATING IN THE SOLUTION. VERBATIM: MATERIAL#: 305211 BATCH#: 4031348 ON 31MAR2025 XXXXXX WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT FOREIGN MATTER FM-SYRINGE ON 31MAR2025, THE HCP REPORTED, ¿ AFTER THE HCP WITHDREW THE DOSE FROM THE VIAL IN THE SUPPLIED SYRINGE THEY NOTICED A SMALL GREEN PARTICLE FLOATING IN THE SOLUTION. THE PRODUCT WAS DEEMED UNUSABLE DUE TO POTENTIAL CONTAMINATION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951814 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