BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LL

    MDR report key: 21885860 · Received April 22, 2025

    Report

    Report Number
    1213809-2025-00292
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    March 21, 2025
    Report Date
    April 30, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    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

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BATCH 3152777 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309628. BATCH#: 3152777. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. 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 ON (B)(6) 2025, THE REPORTER, WHO IS THE HCP, STATED, DOSE WAS WITHDRAWN FROM THE VIAL OF THE SUSPECT EYLEA HD, THE PHYSICIAN NOTICED "ONE PARTICLE" FLOATING INSIDE THE MEDICINE, IN THE VIEWING WINDOW OF THE SYRINGE OF THE SUSPECT EYLEA HD. LOT: 3152777. CATALOG: 309628. PLEASE INITIATE AN INVESTIGATION REGARDING THE 1ML SYRINGE WITH BD CATALOG AND LOT NUMBER: AS THE COMPLAINANT REPORTED UPON DRAWING UP THE DOSE IN THE SYRINGE A PARTICLE WAS NOTED FLOATING IN THE MEDICATION. NO PHOTOGRAPHS OR SAMPLE IS AVAILABLE HOWEVER THE COMPLAINANT DESCRIBED NOTING A PARTICLE ON THE INSIDE OF THE SYRINGE IN THE SOLUTION AFTER DRAWING UP THE DOSE. IT WAS NOTED TO BE ONE PARTICLE FREE FLOATING IN THE SOLUTION. AS WE DO NOT CURRENTLY HAVE ACCESS TO BD BATCH RECORDS, PLEASE ASK BD TO REVIEW BATCH RECORDS AND PROVIDE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560464 BD SYRINGE 1ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3152777 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown