BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 23812386 · Received December 15, 2025

    Report

    Report Number
    1213809-2025-00780
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    October 27, 2025
    Report Date
    January 22, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP. A COSMETIC CONCERN WAS REPORTED INVOLVING OFF COLORED MATERIAL EMBEDDED IN THE SYRINGE GROOVES. TO SUPPORT THE INVESTIGATION, THE QUALITY TEAM RECEIVED ONE PHOTOGRAPH OF A 10ML LUER LOK SYRINGE FOR EVALUATION. THE IMAGE IS A CLOSE UP OF THE SYRINGE BARREL TIP AREA AND INCLUDES A BLUE CIRCLE HIGHLIGHTING AN UNKNOWN, CLEAR COLORED IRREGULARITY WITHIN THE BARREL COLLAR. THE SIZE OF THE IRREGULARITY CANNOT BE DETERMINED FROM THE PHOTOGRAPH, AND THE IMAGE ALONE IS INSUFFICIENT TO CONFIRM WHETHER THE CONDITION ORIGINATED AT THE CANAAN PLANT. A PHYSICAL SAMPLE IS REQUIRED TO ENABLE A COMPREHENSIVE EVALUATION AND SUPPORT POTENTIAL ROOT CAUSE DETERMINATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309605, LOT 5211789. THE REVIEW CONFIRMED THAT ALL REQUIRED VISUAL INSPECTIONS WERE PERFORMED AND THAT NO QUALITY NOTIFICATIONS WERE DOCUMENTED RELATED TO THE REPORTED CONDITION. THE LOT WAS INSPECTED AND ACCEPTED IN ACCORDANCE WITH THE APPROVED INSPECTION CONTROL PLAN, RELEASED FOR SHIPMENT, AND IS CONSIDERED COMPLIANT WITH APPLICABLE PRODUCT SPECIFICATION REQUIREMENTS. TO DATE, NO ADDITIONAL SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, INCLUDING EVALUATION OF THE PHOTOGRAPHIC SAMPLE, THE CUSTOMER REPORTED CONDITION COULD NOT BE CONFIRMED.

    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 TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309605, BATCH#: 5211789. RCC RECEIVED A COMPLAINT VIA EMAIL. UPON VISUAL INSPECTION OF SYRINGES, IT WAS DISCOVERED THAT THERE WERE 205 COSMETIC DEFECTS RELATING TO OFF-COLORED MATTER EMBEDDED IN THE GROOVES OF THE SYRINGE. SOLUTION DOES NOT TOUCH THAT AREA, AND IT DOES NOT MOVE. THE MATTER ALSO APPEARS TO BE COLORED PLASTIC LIKE PARTICLES. ITEM: D309605, LOT#: 5211789, EXPIRY: 06/30/2030.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662781 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5211789 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown