BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23043443 · Received September 12, 2025

    Report

    Report Number
    1911916-2025-00634
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 16, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    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)(6) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT THE OPTIMA COMPONENT BEGINS TO UN-LUER PRIOR TO ANY PRESSURE BEING APPLIED TO THE PLUNGER. TO SUPPORT THE INVESTIGATION, TWO SAMPLES WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. IN ADDITION TO THE PHYSICAL SAMPLES, THREE OPENED AND EMPTY PACKAGING BLISTERS WERE ALSO RECEIVED. A VISUAL INSPECTION WAS CONDUCTED. ONE SAMPLE EXHIBITED NO DEFECTS OR ABNORMALITIES. THE SECOND SAMPLE HAD A BROKEN LUER TIP. PREVIOUS INVESTIGATIONS HAVE CONFIRMED THAT THE LUER TIP MAY FRACTURE WHEN EXCESSIVE TORQUE IS APPLIED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309653, LOT 5142409. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE CUSTOMER-REPORTED SYMPTOM HAS BEEN CONFIRMED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 50ML LL TIP 1ML HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309653, LOT #5142409. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. BD 50ML SYRINGE - REF: 309653, LOT: 5142409. 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
    2655057 BD LUER-LOK PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5142409 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown