BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL SP125

    MDR report key: 23417735 · Received October 29, 2025

    Report

    Report Number
    1213809-2025-00681
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    August 25, 2025
    Report Date
    November 19, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: A FREE-FLOATING PARTICULATE WAS REPORTED. TO SUPPORT THE INVESTIGATION, EIGHT PHOTOGRAPHS WERE PROVIDED FOR EVALUATION BY THE QUALITY TEAM. FOUR IMAGES, TAKEN FROM DIFFERENT ANGLES, DEPICT AN UNIDENTIFIED VIAL WITH AN ATTACHED TIP, FILLED WITH AN UNKNOWN CLOUDY FLUID. ONE IMAGE SHOWS A BROWN PARTICULATE, WHILE TWO ADDITIONAL IMAGES PRESENT THE SAME PARTICULATE UNDER MAGNIFICATION. THE FINAL IMAGE CONTAINS THE RESULTS OF A FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS, INDICATING THE MOST LIKELY MATERIAL MATCH AS ¿POLYACRYLATE-BASED MATERIAL.¿ BASED ON THE AVAILABLE INFORMATION, THE FOREIGN MATTER CANNOT BE CONFIRMED AS ORIGINATING FROM THE CANAAN MANUFACTURING PLANT. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 309646, LOT 5112794. THE REVIEW CONFIRMED THAT ALL VISUAL INSPECTIONS WERE PERFORMED ACCORDING TO REQUIREMENTS, WITH NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION. THE LOT WAS INSPECTED AND ACCEPTED IN ACCORDANCE WITH THE INSPECTION CONTROL PLAN, APPROVED FOR SHIPMENT, AND DEEMED COMPLIANT WITH PRODUCT SPECIFICATION REQUIREMENTS. TECHNICAL AND ELECTRICAL LOGS, AS WELL AS THE PRODUCTION DATABASE, WERE REVIEWED AND REVEALED NO ISSUES ASSOCIATED WITH THE REPORTED CONDITION. ADDITIONALLY, ALL HOUSEKEEPING TASKS WERE DOCUMENTED AS COMPLETED THROUGHOUT THE BATCH RUN. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT.

    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

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309646. LOT # 5112794. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PARTICULATE OBSERVED AT SITE OF CARE XXXX PER SCAR - 00051 ATTACHMENT 1 CHARACTERIZATION REPORT THE COMBINED MORPHOLOGY. CHEMICAL (FT-IR) AND ELEMENTAL (EDS) DATA INDICATE THAT THE FREE-FLOATING PARTICULATE OBSERVED INSIDE OF THE BREYANZI VIAL CD8 HAS CONSISTENCY WITH A POLYACRYLATE-BASED MATERIAL. WHEN DISCOVERED ON (B)(6) 2025. WEIGHT LIMITED TO ONE SYRINGE OF LOT 5112794. MATERIAL NAME - SYRINGE DISPOSABLE LUER-LOK 5ML. VENDOR MANUFACTURING LOT 5112794. PER CUSTOMER. THE DEFECT IN THIS EVENT IS FROM A FREE-FLOATING PARTICULATE WHICH WAS OBSERVED INSIDE A BREYANZI CDB CELLSEAL VIAL. THIS PARTICULATE WAS OBSERVED INSIDE THE CD8 CELLSEAL VIAL AT THE SITE OF CARE, WHICH IS DOWNSTREAM OF THE USE OF THE 5ML SYRINGE. THE AFFECTED PRODUCT WAS NOT ADMINISTERED TO THE PATIENT THE PARTICULATE WAS NOTICED AT THE SITE OF CARE DURING THAWING, PRIOR TO INOCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215426 BD SYRINGE 5ML LL SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5112794 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown