BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 22182969 · Received June 11, 2025

    Report

    Report Number
    1213809-2025-00387
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    May 22, 2025
    Report Date
    August 25, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. A TOTAL OF ONE THOUSAND EIGHTY-SEVEN SAMPLES AND THREE PHOTOS OF 3ML LUER-LOK SYRINGES (PART NUMBER 309657), BATCH 5083610, WERE RECEIVED AND EVALUATED. ALL SAMPLES ARRIVED IN SEALED PACKAGES WITH COMPLETE PRODUCT LABELING. OF THE SAMPLES INSPECTED, EIGHT HUNDRED TWENTY-EIGHT WERE FREE OF DEFECTS AND MET PRODUCT SPECIFICATIONS. INK STAINS ON THE BARREL COLLAR WERE OBSERVED IN TWO HUNDRED FIFTY-NINE SAMPLES; FORTY-NINE WERE DEEMED ACCEPTABLE, AS THEY DID NOT IMPACT FORM, FIT, OR FUNCTION. HOWEVER, TWO HUNDRED TEN SAMPLES EXHIBITED INK STAINS CONSIDERED NON-CONFORMING PER PRODUCT SPECIFICATIONS. SUPPORTING PHOTOS INCLUDED ONE SYRINGE WITH A NON-CONFORMING INK STAIN, PROVIDING VISUAL DOCUMENTATION OF THE FINDINGS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR THE PROVIDED LOT NUMBER 5083610. THE REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. THIS INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL 200 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309657. BATCH # 5083610. VERBATIM: DISCOLORATION IN THE PACKAGE NEAR THE TIP AND PARTICLES FOUND IN PACKAGING OF 309657. STAFF DISCOVERED WHILE USING A FEW OF THE 3ML SYRINGES FOR PATIENT CARE A FOREIGN SUBSTANCE/OBJECT IN THE 3ML SYRINGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91209 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5083610 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown