BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL

    MDR report key: 21915935 · Received April 27, 2025

    Report

    Report Number
    1911916-2025-00312
    Event Type
    Malfunction
    Date Received
    April 27, 2025
    Date of Event
    February 14, 2025
    Report Date
    May 7, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903052111
    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

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT WAS REPORTED THERE WERE PARTICLES IDENTIFIED IN THE SYRINGE FOLLOWING THE DRAWING UP OF THE DOSE. AS THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO AID IN THE INVESTIGATION, ONE PHOTOGRAPH WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOGRAPH SHOWS A SYRINGE WITH SOLUTION AND A CIRCLED AREA WHERE THERE APPEARS TO BE AN AIR BUBBLE. NO ADDITIONAL INFORMATION COULD BE DERIVED FROM THE PHOTOGRAPH. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211, LOT 4031348. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND THE ANALYSIS OF THE PHOTOGRAPH, THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WITHOUT THE PHYSICAL SAMPLE FOR ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MATERIAL # 305211. BATCH # 4031348. IT WAS REPORTED BY CUSTOMER THAT THEY NOTICED PARTICLES IDENTIFIED IN THE SYRINGE FOLLOWING THE DRAWING UP OF THE DOSE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT DESCRIPTION ON (B)(6) 2025 (B)(6) WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT FOREIGN MATTER FM- SYRINGE. ON (B)(6) 2025, THE REPORTER, WHO IS THE HCP, STATED, ¿NOTICED PARTICLES IDENTIFIED IN THE SYRINGE FOLLOWING THE DRAWING UP OF THE DOSE.¿ INVESTIGATIONAL REQUEST /RETURN COMPONENT STATUS SAMPLE WAS RETURNED. PLEASE PROVIDE WHAT CONTROLS ARE IN PLACE TO DETECT MANUFACTURING DEFECTS THAT MAY LEAD TO FOREIGN MATTER FOR THE FILTER NEEDLE AND SYRINGE LOT IN QUESTION. PLEASE PROVIDE HOW BD TESTS THE FUNCTIONALITY OF THE FILTER IN THE FILTER NEEDLE AND HOW IT MAY RELATE TO CHLOROBUTYL RUBBER PARTICLES FOUND IN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326422 NEEDLE FILTER BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4031348 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown