BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 22645385 · Received July 29, 2025

    Report

    Report Number
    9610847-2025-00231
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    June 17, 2025
    Report Date
    September 26, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097020
    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

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 4 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION OF THE PHOTOS. ANALYSIS OF THE SAMPLE SHOWED THAT ONE OF THE PHOTOS SHOW A SYRINGE WITH AN UNKNOWN BLACK MARK ON THE BARREL, ANOTHER PHOTO SHOWS COLLAR FLASH ON THE BARREL AND ANOTHER PHOTO SHOWS AN UNKNOWN BLACK PARTICULATE BELOW THE STOPPER. BD DETERMINED THE CAUSE OF THE BARREL FLASH IS ASSOCIATED WITH THE MOLDING PROCESS AND THE CAUSE OF THE FOREIGN MATTER COULD NOT BE DETERMINED FROM THE PHOTOS PROVIDED. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE OF THE REPORTED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK HAS FOREIGN MATTER MATERIAL # 309702, BATCH # 5007825, 5007822, IT WAS REPORTED BY CUSTOMER THAT DEBRIS ON INSIDE OF SYRINGE BARREL AND PLUNGER LEAKING AND DEFECT ON SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DEBRIS ON INSIDE OF SYRINGE BARREL PLUNGER LEAKING, DEFECT ON SYRINGE, MATERIAL# BD 309702, (3ML SYRINGE) CUSTOMER RESPONSE ON 21-JUL-2025. PLEASE SEE THE ATTACHED PHOTOS FOR THIS PRODUCT COMPLAINT. WE CANNOT SEND SAMPLES. 5007825 ¿ DEBRIS IN BARREL OF SYRINGE 5007825 ¿ DEFECT ON SYRINGE TIP 5007825 ¿ PLUNGER LEAKING, LIQUID LEAKING THROUGH TOP RING OF PLUNGER STOPPER, DROPS NEAR THE 2.1 AND 2.6 MARKING 5072050 ¿ DEBRIS HANGING FROM PLUNGER STOPPER.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: APOLOGIES, THE LEAKING PLUNGER ISSUE WAS FOR LOT #5007822 (PHOTO OF SYRINGE WITH RED CAP) I WROTE THE WRONG LOT NUMBER IN MY PREVIOUS EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886821 BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5007825 30382903097020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown