BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23043883 · Received September 12, 2025

    Report

    Report Number
    1213809-2025-00600
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 28, 2025
    Report Date
    October 29, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THAT THE OPTIMA COMPONENT DETACHED FROM THE SYRINGE PRIOR TO ANY PRESSURE BEING APPLIED TO THE PLUNGER. TO SUPPORT THE INVESTIGATION, ONE SAMPLE OF A 10 ML LUER-LOK SYRINGE FROM LOT 5037755 WAS SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. THE SAMPLE ARRIVED IN UNSEALED PACKAGING AND EXHIBITED DAMAGE TO THE BARREL'S LUER CONNECTION. THIS CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATIONS AND IS ATTRIBUTED TO THE ASSEMBLY PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR MATERIAL NUMBER 302995, LOT 5037755. THE REVIEW CONFIRMED THAT ALL VISUAL INSPECTIONS WERE COMPLETED IN ACCORDANCE WITH ESTABLISHED REQUIREMENTS, AND NO QUALITY NOTIFICATIONS WERE RECORDED RELATED TO THE REPORTED ISSUE. THE LOT WAS INSPECTED AND ACCEPTED BASED ON THE INSPECTION CONTROL PLAN, APPROVED FOR SHIPMENT, AND FOUND TO BE IN COMPLIANCE WITH PRODUCT SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #302995. LOT #5037755. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. BD 10ML SYRINGE - REF: 302995. LOT: 5037755. WHEN THE PHARMACISTS ARE LUERING AN OPTIMA INJECTOR ONTO ANY SYRINGE (BD 50ML SYRINGE - REF: 309653 LOT: 5142409, BD 10ML SYRINGE - REF: 302995. LOT: 5037755, BD 20ML SYRINGE - REF: 302830 LOT: 5120041), THEY ARE FINDING IT HARD TO LUER ON COMPLETELY AND FINDING THAT THE OPTIMA PIECE UNLURES ON ITS OWN SLIGHTLY BEFORE APPLYING ANY PRESSURE TO THE PLUNGER. ALSO, WHEN THEY DO APPLY DOWNWARD PRESSURE TO THE SYRINGE, IT IS ALSO A POINT WHERE THE LUERED CONNECTION HAS COME COMPLETELY UNLURED. THEY ATTEMPTED TO REPLICATE THE CHALLENGE WITH OTHER MALE LUER DEVICES ONTO THE SAME FEMALE LUER TIP OF THE SYRINGE AND THIS DID NOT HAPPEN, WHICH SUGGESTS THAT IT IS ISOLATED TO THE OPTIMA INJECTOR. FOR YOUR INVESTIGATION, THEY ALSO WOULD LIKE TO PROVIDE THE THREE SYRINGES THEY TRIED TO LUER ON TO THE OPTIMA INJECTOR FOR YOUR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180588 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5037755 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown