BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 23000299 · Received September 9, 2025

    Report

    Report Number
    9610847-2025-00299
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    June 17, 2025
    Report Date
    October 17, 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
    PHARMACIST
    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 8 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED THAT THERE WERE FOREIGN PARTICULATES ON THE SYRINGE SAMPLES. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS RELATED TO INCORRECT HANDLING OF MATERIALS DURING THE MANUAL LOADING PROCESS OF THE SYRINGES INTO THE TRAYS DURING MANUFACTURING. A RETRAINING OF MANUFACTURING PERSONNEL WAS PERFORMED TO ADDRESS THIS ISSUE. 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 THE BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309702 BATCH # 5007825, 5007822, 5013796, 5007821. IT WAS REPORTED BY CUSTOMER THAT "DEBRIS ON INSIDE OF SYRINGE BARREL, PLUNGER LEAKING, DEFECT ON SYRINGE, DEBRIS ON SYRINGE TIP, DEBRIS, SILICONE RUNNING ON PLUNGER BARREL, SYRINGE BARREL CROOKED, PLUNGER CRACKED, PLUNGER CROOKED, PLUNGER BROKEN." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DEBRIS ON INSIDE OF SYRINGE BARREL, PLUNGER LEAKING, DEFECT ON SYRINGE, DEBRIS ON SYRINGE TIP, DEBRIS, SILICONE RUNNING ON PLUNGER BARREL, SYRINGE BARREL CROOKED, PLUNGER CRACKED, PLUNGER CROOKED, PLUNGER BROKEN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2522865 BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5007825 30382903097020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown