BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 23444239 · Received October 31, 2025

    Report

    Report Number
    1213809-2025-00691
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 9, 2025
    Report Date
    December 8, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. TWO LOOSE 10 ML LUER-LOK SYRINGE (PART NUMBER 309605) AND TWO PHOTOS WERE RECEIVED AND EVALUATED. THE SAMPLE SHOWED SIGNIFICANT DAMAGE TO THE PLUNGER ROD, WHILE THE PHOTOS DEPICTED SYRINGES FILLED WITH AN UNKNOWN CLEAR FLUID CONTAINING DARK, THREAD-LIKE PARTICULATES OF UNDETERMINED SIZE. THE FOREIGN MATTER WAS NOT PRESENT IN THE RECEIVED SAMPLES. THESE CONDITIONS ARE NON-CONFORMING TO PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE FOR BOTH THE FOREIGN MATTER IN THE FLUID PATH AND THE PLUNGER ROD DAMAGE IS ASSOCIATED WITH THE ASSEMBLY PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW FOR LOT NUMBERS 4354977 AND 5211788 REVEALED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    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 WAS PROVIDED.

    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 LOT # UNKNOWN (POTENTIAL LOT 5211788,4354977) VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED DURING COMPOUNDING OF LOT #20251009-041C88 ONE SYRINGE WAS FOUND TO HAVE A FOREIGN PARTICULATE THAT APPEARED DARK IN COLOR AND DIFFERENT THAN TYPICAL MEDIA PARTICULATE SEEN. THE UNIT IS AVAILABLE FOR RETURN. 10/9/2025 PCC-25-136 STERILE SYRINGE TRAY 10ML 309605 EXPIRY 6/30/2030 AND 11/30/2029 5211788, 4354977 FOREIGN PARTICULATE DARK STRAND 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234333 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown