BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 23581956 · Received November 18, 2025

    Report

    Report Number
    1213809-2025-00725
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 16, 2025
    Report Date
    January 7, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903009121
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    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 - VOLUMETRIC ACCURACY. TWO SAMPLES OF 10 ML LUER-LOK SYRINGES (PART NUMBER 300912), BATCH 5163315, WERE RECEIVED FOR EVALUATION¿ONE IN SEALED PACKAGING WITH COMPLETE PRODUCT INFORMATION AND ONE RECEIVED LOOSE. BOTH SAMPLES UNDERWENT VOLUMETRIC ACCURACY TESTING AND MET ACCEPTABLE PERFORMANCE LIMITS. THE OBSERVED CONDITION IS ACCEPTABLE PER PRODUCT SPECIFICATIONS. ADDITIONALLY, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR THE PROVIDED LOT NUMBER 5163315. THIS REVIEW IDENTIFIED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. RELEVANT INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED ON A MONTHLY BASIS. THE COLLECTED DATA ARE REGULARLY REVIEWED BY THE BUSINESS TEAM TO IDENTIFY ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL EUROGRAPHICS HAD AN ISSUE WITH VOLUMETRIC ACCURACY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEVICE REFERENCE: 300912. NUMBER OF CASES: 1. BATCH: 5163315. DATE OF INCIDENT: (B)(6) 2025. THE NOTIFIER REPORTS A DEFECT IN THE PRODUCT: LUER LOCK SYRINGE 3 PIECES 10ML STERILIZED BY GAMMA RADIATION (PLASTIPAK), REF 300912, LOT 5163315 "WE PREPARE CHEMOTHERAPY BAGS BY DRAWING THE CYTOTOXIC DRUG USING 10ML SYRINGES. SEVERAL TIMES, ANALYTICAL TESTS OF THE CHEMOTHERAPY BAGS HAVE REVEALED NON-CONFORMITIES, LEADING TO THE DESTRUCTION OF THE BAGS. AFTER CHECKING THE VOLUMES OF THE 10ML SYRINGES: WHEN FILLED TO THE 10ML GRADUATION MARK, THEY CONTAIN ONLY 9.77MG OF WATER, I.E., 9.77ML. THIS INACCURACY CAUSES ERRORS OF MORE THAN 10% IN SOME PREPARATIONS AND FORCES US TO DISCARD OUR BAGS." PRODUCTION PROBLEM? CORRECTIVE MEASURES: DESTRUCTION OF BAGS DUE TO INACCURACY, PREPARATION OF NEW BAGS. CLINICAL CONSEQUENCES: NO VICTIMS. IN VIEW OF AN EXPERT ASSESSMENT, THE RESULTS OF WHICH WE WOULD LIKE TO KNOW AS SOON AS POSSIBLE, WE ARE KEEPING TWO OF THE DEVICES IN QUESTION (ONE INCRIMINATED AND ONE NEW FROM THE SAME BATCH) AT THE BRABOIS HOSPITALS PHARMACY. WE WILL ASK YOU TO ARRANGE FOR THE RETURN OF THIS DEVICE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116106 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5163315 00382903009121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown