BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 22298655 · Received June 20, 2025

    Report

    Report Number
    1213809-2025-00419
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    June 2, 2025
    Report Date
    August 13, 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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 - BARREL CRACKED. TWO PHOTOS OF A 3ML SYRINGE, PART NUMBER 309657 AND BATCH NUMBER 4131474, WERE REVIEWED. ONE PHOTO SHOWS THE PACKAGE WITH ALL RELEVANT PRODUCT INFORMATION, WHILE THE OTHER DISPLAYS A LOOSE SYRINGE WITH A CRACK EXTENDING FROM THE 1/2 ML TO THE 1-1/2 ML GRADUATION LINE, ALONG WITH A WHITE DISCOLORATION BETWEEN THE 2 ML AND 2-1/2 ML MARKS. THE CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE OF THE CRACKED BARREL IS LINKED TO THE ASSEMBLY PROCESS. HOWEVER, DUE TO THE LIMITATIONS OF PHOTOGRAPHIC EVIDENCE, THE ORIGIN OF THE DISCOLORATION COULD NOT BE CONFIRMED, AND NO DEFINITIVE ROOT CAUSE WAS IDENTIFIED. A PHYSICAL SAMPLE IS REQUIRED FOR FURTHER EVALUATION AND ROOT CAUSE DETERMINATION. ADDITIONALLY, A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR LOT NUMBER 4131474, WHICH 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, WITH OUR BUSINESS TEAM REGULARLY REVIEWING THE COLLECTED DATA TO IDENTIFY ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL 200 S/C BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309657. BATCH#: 4131474. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. GOOD AFTERNOON. I WANTED TO CONNECT YOU WITH MY CLINIC MANAGER. OUR STAFF HAS REPORTED DEFECTS AND BROKEN SYRINGES WHEN BEING USED FOR PATIENT CARE. BOTH THE 3ML (#309657) AND 5ML (#309646) HAVE DISPLAYED DEFECTS THAT CAUSED MEDICATION TO LEAK OUT ONTO A PATIENT. IN ONE CASE THERE WAS A CRACK IN THE SYRINGE AND THE OTHER THERE WERE 2 HOLES IN THE SYRINGE. CAN YOU PLEASE FILE A PRODUCT INCIDENT REPORT AND GUIDE ON NEXT STEPS? THANK YOU.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202146 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4131474 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown