BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 23149989 · Received September 25, 2025

    Report

    Report Number
    1213809-2025-00621
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    September 9, 2025
    Report Date
    November 11, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION THREE PHOTOS AND TEN SAMPLES OF 10 ML LUER-LOK SYRINGES (PART NUMBER 309646) FROM BATCHES 5030603 AND 5149753 WERE RECEIVED AND EVALUATED. INSPECTION CONFIRMED NORMAL SILICONE QUANTITIES WITHIN THE FLUID PATH, AND NO FOREIGN MATTER WAS OBSERVED, CONSISTENT WITH PRODUCT SPECIFICATIONS. PHOTO REVIEW ALIGNED WITH PHYSICAL SAMPLE OBSERVATIONS. THE ¿WET CONSISTENCY¿ NOTED IS SILICONE, AN INERT, NON-TOXIC MEDICAL LUBRICANT ESSENTIAL FOR SYRINGE FUNCTIONALITY, WIDELY USED FOR OVER 25 YEARS WITHOUT REPORTED ADVERSE EFFECTS. SILICONE DOES NOT IMPACT SAFETY, EFFICACY, OR PRODUCT PERFORMANCE. PLEASE SEE THE ATTACHED SILICONE QUANTITY GUIDELINE FOR REFERENCE. ADDITIONALLY, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT NUMBERS 5030603 AND 5149753, WHICH SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    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 10ML LL S/C 200 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT SYRINGES SEEM TO HAVE A WET CONSISTENCY IN THE SYRINGE. RCC RECEIVED A COMPLAINT VIA EMAIL. SYRINGES SEEM TO HAVE A WET CONSISTENCY IN THE SYRINGE. MAKING IT NOT USABLE FOR THE CUSTOMERS. MANY PICTURES AND SYRINGES HAVE COME LOOKING WET NOT AS IF THE PLUNGER IS FULLY PRESSED BUT WHEN THE PLUNGER IS TAKEN OUT AS WELL. O PRODUCT#: 302995 & 309646. LOT#: 5030603 (10ML) 5149753 (10ML) 517003 (5ML) 5149753 (10ML). ADDITIONAL INFORMATION PROVIDED: FOR (B)(4). 1. COULD YOU PLEASE PROVIDE THE QUANTITY AFFECTED FOR EACH LOT? 7 BOXES 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 09/09/2025 3. COULD YOU KINDLY CONFIRM IF ANY SAMPLES ARE AVAILABLE FOR RETURN SO WE CAN PROCEED WITH FURTHER INVESTIGATION? IF SO, WOULD YOU BE ABLE TO PROVIDE THE FACILITY ADDRESS WHERE WE CAN SEND THE RETURN SHIPPING LABEL? YES, ALL BOXES AVAILABLE FOR PICKUP, (B)(6). 4. PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE? YES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2765379 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5149753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown