BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 22322866 · Received June 24, 2025

    Report

    Report Number
    1213809-2025-00431
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    June 2, 2025
    Report Date
    August 12, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903050642
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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 - PACKAGE DAMAGED / DEFECTIVE / OTHER. FOUR SAMPLES OF 10 ML LUER-LOK SYRINGES WITH 18X1-1/2" BLUNT FILL NEEDLES WERE RECEIVED FOR EVALUATION, ALL IN UNSEALED PACKAGES WITH COMPLETE PRODUCT INFORMATION VISIBLE ON THE TOP WEB. THE SAMPLES INCLUDED TWO FROM BATCH 5071719, ONE FROM BATCH 5077470, AND ONE FROM BATCH 5043395. EACH EXHIBITED AN OPEN SIDE SEAL EXCEEDING 6 INCHES WITH GRID MARKS, WHICH IS NON-CONFORMING PER PRODUCT SPECIFICATIONS. POTENTIAL ROOT CAUSE FOR THE PACKAGE OPEN SEAL DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 5043395, 5077470, AND 5071719. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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 SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL PACKAGING WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305064. BATCH#: 5043395. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM: 305064. QUANTITY AFFECTED: (B)(4). SERIAL/LOT NUMBER: (B)(6). PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE PEEL POUCHES ARE NOT SEALED UPON RECEIPT TO THE CUSTOMER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064051 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5071719 00382903050642

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown