BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21349541 · Received February 10, 2025

    Report

    Report Number
    1213809-2025-00080
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 23, 2025
    Report Date
    April 5, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) - SUPPLEMENTAL MDR - LEAKAGE OTHER. ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON EVALUATION, IT WAS OBSERVED THAT SYRINGE HAS THE BARREL CRACKED ALL THE WAY THROUGH ALONG THE SIDE. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE BARREL CRACKED DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1152173. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 1152173 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. 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.

    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

    IT WAS REPORTED THAT THE BD LUER-LOK HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: JUST EMAILING TO INFORM YOU OF A FAULT WITH THE BD PLASTIPAK 10 ML SYRINGES. LOT CODE IS 1152173. IT WAS NOTED BY DR. (B)(6) WHEN USING THEM WITH A PATIENT THERE IS A SPLIT DOWN THE SYRINGE CAUSING LEAKAGE OF MEDICATION. CAN YOU PLEASE FEED BACK TO THE COMPANY. I HAVE ASKED HER TO COMPLETE AN INCIDENT FORM. I CAN LEAVE THE SYRINGE IN THE LILY CLEAN UTILITY IF NEEDED. ADDITIONAL INFORMATION PROVIDED: 1) WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN - NO. 2) COULD YOU PLEASE PROVIDE AN EVENT OCCURRENCE DATE? 23/01/2025. 3) COULD YOU PLEASE SHARE THE SAMPLE STATUS CONTAMINATED OR NOT? YES. 4) SAMPLE AVAILABILITY: YES. COULD YOU PLEASE CONFIRM IF ANY SAMPLES ARE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE SPECIFY IF THE SAMPLES ARE: UNUSED (BEFORE USE). USED (DURING OR AFTER USE) - YES. IMPORTANT: IF USED, PLEASE CONFIRM IF THE SAMPLES ARE CONTAMINATED WITH BLOOD OR CYTOTOXIC MEDICATION. NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708527 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1152173

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown