BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL SP125

    MDR report key: 23011468 · Received September 9, 2025

    Report

    Report Number
    1213809-2025-00584
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 20, 2025
    Report Date
    October 10, 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
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION A REPORT WAS RECEIVED INDICATING THAT ONE 5ML SYRINGE EXHIBITED BROWN DISCOLORATION. TO SUPPORT THE INVESTIGATION, OUR QUALITY TEAM EVALUATED ONE LOOSE SAMPLE AND TWO PHOTOGRAPHS OF A 5ML LUER-LOK SYRINGE. THE PHYSICAL SAMPLE DISPLAYED FOUR BROWN DISCOLORATION SPOTS ON THE BARREL, CONSISTENT WITH EMBEDDED FOREIGN MATTER. THE PHOTOGRAPHS PROVIDED SHOW A SYRINGE FROM DIFFERENT ANGLES, CLEARLY DEPICTING THE DISCOLORATION OBSERVED ON THE SAMPLE. THE CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATIONS AND IS ATTRIBUTED TO THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC, WHICH CAN OCCUR WHEN RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES WITHIN THE MOLDING MACHINE, SUCH AS DURING START-UP. THIS DEFECT IS COSMETIC IN NATURE AND DOES NOT POSE A RISK TO THE CUSTOMER. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 309646, LOT 5071117. THE REVIEW CONFIRMED THAT ALL VISUAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH ESTABLISHED REQUIREMENTS, WITH NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION. THE LOT WAS INSPECTED AND ACCEPTED PER THE INSPECTION CONTROL PLAN, APPROVED FOR SHIPMENT, AND DEEMED COMPLIANT WITH PRODUCT SPECIFICATION REQUIREMENTS. TO DATE, NO ADDITIONAL SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT.

    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, BATCH#: 5071117. RCC RECEIVED A COMPLAINT VIA EMAIL. DURING COMPOUNDING OF LOT#: 20250820-8C7E96 ONE 5ML SYRINGE WAS FOUND TO HAVE BROWN SPOTS. ONE SYRINGE IS AVAILABLE FOR RETURN. PRODUCT#: 309656, LOT#: 5071117. ADDITIONAL INFO: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 20-AUG-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2831778 BD SYRINGE 5ML LL SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5071117 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown