BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 22333146 · Received June 25, 2025

    Report

    Report Number
    1213809-2025-00442
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 9, 2025
    Report Date
    July 4, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BATCH 5076657 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WOULD LIKE TO REPORT SOME ISSUES WITH SOME OF OUR 1ML BD SYRINGE STOCK. WE HAVE HAD SOME REPEATED INSTANCES OF PARTICLES FOUND IN THE SYRINGES BEFORE USE, AT THE POINT OF ASEPTIC PREPARATION. OFTEN, SOME OF THE GRADUATION LINES ON THE SYRINGES ARE RUBBED OFF OR TOO FAINT TO READ VOLUMES. WE UNDERSTAND IT IS POSSIBLE NOT ALL OF THE SYRINGES ARE AFFECTED; HOWEVER, IT STILL POSES A RISK TO THE PRODUCTS WE MAKE. BATCH NUMBER OF 1ML AFFECTED: 507665719, EXPIRY: 28-02-2030. WE HAD A PREVIOUS ISSUE REPORTED WITH 10ML SYRINGES, WITH COMPLAINT ORDER (B)(4). PLEASE PROVIDE ANY FEEDBACK YOU CAN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175242 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5076657 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown