BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 22100505 · Received May 28, 2025

    Report

    Report Number
    1213809-2025-00354
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 1, 2025
    Report Date
    July 22, 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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER TWO PHOTOS AND ONE PHYSICAL SAMPLE OF A 10 ML LL SYRINGE (MATERIAL 309605) WERE RECEIVED AND EVALUATED AS PART OF THE INVESTIGATION. BOTH IMAGES SHOWED A FULLY ASSEMBLED SYRINGE CONTAINING A 1 ML STOPPER FLOATING WITHIN THE FLUID PATH, SUBMERGED IN A TRANSPARENT LIQUID. THE PHYSICAL SAMPLE CONFIRMED THE SAME CONDITION OBSERVED IN THE PHOTOS. THE FOREIGN MATERIAL WAS IDENTIFIED AS A 1 ML STOPPER, WHICH IS NON-CONFORMING PER PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE OF THIS FOREIGN MATTER IN FLUID PATH DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 4309119 AND 4241620. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED 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

    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 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 BATCH#: UNKNOWN. RCC RECEIVED A COMPLAINT VIA EMAIL. THERE WAS A FOREIGN OBJECT SPOTTED INSIDE THE BARREL OF A BD SYRINGE. IT APPEARS TO BE A TIP CAP OF SOME KIND. PLEASE SEE THE 2 PICS THAT ACCOMPANY THIS REPORT. THE CUSTOMER HAS ALSO RETAINED THE ITEM TO BE RETURNED FOR INSPECTION. PLEASE MAKE ARRANGEMENTS TO HAVE A RETURN KIT SENT TO THE CUSTOMER. PRODUCT NUMBER - 309605 LOT NUMBER - 4309119 OR 4241620.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362117 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