BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 23543592 · Received November 13, 2025

    Report

    Report Number
    9610847-2025-00422
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 21, 2025
    Report Date
    December 16, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903056187
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 3 PHOTOS AND 1 PHYSICAL SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT THE SYRINGE RUBBER STOPPER-PLUNGER ROD HAS AT THE TIP WHAT APPEARS TO BE SILICONE LUBRICANT. FTIR TESTING WAS NOT ABLE TO RELIABLY DETERMINE THE FOREIGN MATERIAL, BUT BASED ON THE SIMILARITY OF THE RESULTS IT IS LIKELY RELATED TO OR CONTAMINATED BY A SILICONE DERIVATIVE. BD WAS NOT ABLE TO DETERMINE THE CAUSE OF THE FAILURE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 30ML LL TIP CONV PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305618. BATCH#: 5112150. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I PULLED THIS EMAIL TO REPORT ONCE AGAIN THE SAME ISSUE WE HAD IN THE PAST ((B)(6)2025). ONE OF THE 30 CC SYRINGE LOT IS HAVING THIS GROWTH LIKE MATERIAL AFTER FILLING. IT SHOWS CLOUDINESS AFTER FILLING. IN ONE OF THE PICTURES, IT'S VERY CLEAR THE GROWTH/FOREIGN MATERIAL IS ON THE TOP OF PLUNGER. WE ALSO HAD A COMPLAINT FROM THE CUSTOMER AS WELL. WE HAVE SEGREGATED THESE SYRINGES AND KEPT THEM FOR YOUR INVESTIGATION ONCE AGAIN. WE WOULD LIKE TO PUT THIS 30 CC SYRINGE LOT 5112150 ON HOLD. I AM INCLUDING MY WAREHOUSE MANAGER AS WELL IN THIS EMAIL SO WE CAN SEE IF WE HAVE ANOTHER LOT TO USE. BUT THIS IS A VERY URGENT MATTER. 30 CC SYRINGE TRAY (BD). SYRINGE LOT NUMBER: 5112150. EXP. DATE: 2030-03-31. QTY: (B)(4) AND KEPT INCREASING AS SOON AS WE USE. ADDITIONAL INFORMATION PROVIDED: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. ANSWER: SINCE THIS SYRINGE WAS NOT USED FOR ANY PATIENT AND WAS CAUGHT AFTER FILLING DURING VISUAL INSPECTION PROCESS. NO PATIENT WAS INVOLVED. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? ANSWER: (B)(6) 2025. THERE WERE TWO SEPARATE BATCHES FROM OUR INTERNAL SYRINGE BATCHES. BOTH INVOLVED THE SAME SYRINGE LOT 5112150. THIS LOT 5112150 WAS PUT ON HOLD AND STARTED USING NEXT LOT 5129092. TOTAL AFFECTED SYRINGES SO FAR ARE 4, WHICH THE SAMPLES ARE AVAILABLE FOR YOUR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141485 LUER-LOK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5112150 00382903056187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown