BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21440819 · Received February 22, 2025

    Report

    Report Number
    1213809-2025-00122
    Event Type
    Malfunction
    Date Received
    February 22, 2025
    Date of Event
    December 23, 2024
    Report Date
    March 17, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). STOPPER DEFECTIVE / DAMAGED. TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. BOTH PHOTOS SHOW CLOSE-UP VIEWS OF A FULLY ASSEMBLED LOOSE SYRINGE. A DISTORTED STOPPER IS CLEARLY VISIBLE BETWEEN THE PLUNGER ROD AND AROUND THE NUMBERS 2 AND 3 ON THE BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. THE POTENTIAL ROOT CAUSE FOR THE DISTORTED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3152777. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    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

    MATERIAL #:309628. BATCH#:3152777. IT WAS REPORTED THAT THE BD LUER-LOK STOPPER WAS DEFECTIVE / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE CI ¿ STOPPED SEPARATED FROM SYRINGE PLUNGER AND AFTER THE MEDICATION WAS DRAWN INTO THE SYRINGE, THE RUBBER ON THE PLUNGER END OF THE SYRINGE BROKE AND MEDICATION SPILLED FROM THE PLUNGER END OF THE SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ¿AFTER THE MEDICATION WAS DRAWN INTO THE SYRINGE, THE RUBBER ON THE PLUNGER END OF THE SYRINGE BROKE AND MEDICATION SPILLED FROM THE PLUNGER END OF THE SYRINGE.¿ CATALOG #: 309628. LOT #: 3152777. ON (B)(6)2025, REGENERON WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE CI ¿ STOPPED SEPARATED FROM SYRINGE PLUNGER ON (B)(6)2024, THE REPORTER, WHO IS THE HCP, STATED, ¿AFTER THE MEDICATION WAS DRAWN INTO THE SYRINGE, THE RUBBER ON THE PLUNGER END OF THE SYRINGE BROKE AND MEDICATION SPILLED FROM THE PLUNGER END OF THE SYRINGE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667100 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3152777 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown