BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 22857086 · Received August 20, 2025

    Report

    Report Number
    1213809-2025-00563
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    August 6, 2025
    Report Date
    October 30, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903009121
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 - LEAKAGE. FOLLOWING THE CONNECTION OF THE SYRINGE TO THE PUMP, A LEAK WAS OBSERVED ORIGINATING FROM THE SYRINGE BODY. TO SUPPORT THE INVESTIGATION, FOUR PHOTOS AND ONE SAMPLE WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. ONE IMAGE PROVIDES A CLOSE-UP OF THE CARTON BOX LABEL, DISPLAYING ALL RELEVANT PRODUCT INFORMATION. ANOTHER IMAGE CAPTURES THE TOP WEB SLIP, WHICH INCLUDES THE APPLICABLE PRODUCT SPECIFICATIONS. WHILE THE SYRINGE APPEARS IDENTICAL IN BOTH PHOTOGRAPHS, A PROMINENT CRACK IS VISIBLE IN THE NON-SCALE MARKING AREA OF THE BARREL, SPECIFICALLY NEAR THE LOWER END. THE CONSISTENT LOCATION OF THE DAMAGE SUGGESTS THAT BOTH IMAGES DEPICT THE SAME UNIT. NOTABLY, THE FLUID INSIDE THE SYRINGE DIFFERS IN COLOR BETWEEN THE TWO PHOTOS. A PHYSICAL SAMPLE WAS INSPECTED AND CONFIRMED TO EXHIBIT THE SAME CRACK CONDITION AS OBSERVED IN THE PHOTOGRAPHS. THIS CONDITION DOES NOT CONFORM TO PRODUCT SPECIFICATIONS AND IS ATTRIBUTED TO THE ASSEMBLY PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR MATERIAL NUMBER 300912, LOT 5083084. THE REVIEW CONFIRMED THAT ALL VISUAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH ESTABLISHED REQUIREMENTS, AND NO QUALITY NOTIFICATIONS WERE RECORDED RELATED TO THE REPORTED CONDITION. THE LOT WAS INSPECTED AND ACCEPTED BASED ON THE INSPECTION CONTROL PLAN, APPROVED FOR SHIPMENT, AND DEEMED COMPLIANT WITH PRODUCT SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL EUROGRAPHICS HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DID THE INCIDENT OCCUR? DURING USE "AFTER CONNECTING THE SYRINGE TO THE PUMP, A LEAK STARTED FROM THE SYRINGE BODY. THE SYRINGE CONTAINED TPN." ADDITIONAL INFORMATION PROVIDED: ¿ IS THE PUMP CONNECTED TO THE PATIENT = YES ¿ WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN = NO ¿ WAS THE HCP PRESENT WHEN THE ISSUE OCCURRED? = YES ¿ IF LEAKAGE OCCURRED, PLEASE CONFIRM THE FLUID THAT LEAKED= TPN ¿ WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? IF YES, PLEASE EXPLAIN ¿ NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203633 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5083084 00382903009121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown