BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL SP125

    MDR report key: 23196782 · Received October 1, 2025

    Report

    Report Number
    1213809-2025-00625
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 9, 2025
    Report Date
    November 10, 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. FIVE SAMPLES OF 5 ML LUER-LOK SYRINGES (PART NUMBER 309646, BATCH 5175003) WERE RECEIVED AND EVALUATED. INSPECTION CONFIRMED NORMAL SILICONE QUANTITIES WITHIN THE FLUID PATH AND NO FOREIGN MATTER, CONSISTENT WITH PRODUCT SPECIFICATIONS. THE OBSERVED ¿WET CONSISTENCY¿ IS SILICONE, AN INERT, NON-TOXIC MEDICAL LUBRICANT INTEGRAL TO SYRINGE FUNCTIONALITY AND 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 NUMBER 5175003, 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 5ML LL SP125 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309646 BATCH#: 5175003. VERBATIM: 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. PRODUCT#: 302995 & 309646. LOT#: 5030603 (10ML) 5149753 (10ML) 517003 (5ML) 5149753 (10ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433913 BD SYRINGE 5ML LL SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5175003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown