BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23953930 · Received January 4, 2026

    Report

    Report Number
    9614033-2025-00127
    Event Type
    Malfunction
    Date Received
    January 4, 2026
    Date of Event
    December 9, 2025
    Report Date
    March 24, 2026
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903033102
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: TWO PHOTOS, TWENTY UNUSED SAMPLES, AND TWO USED SAMPLES WERE RECEIVED BY OUR QUALITY FOR EVALUATION. IN THE PHOTOS AND USED SAMPLES, A FOREIGN MATERIAL COULD BE OBSERVED; THEREFORE, THE REPORTED INCIDENT COULD BE VERIFIED. HOWEVER, THE FOREIGN MATERIAL WAS SENT FOR FTIR ANALYSIS AND THE RESULTS OBTAINED DO NOT CORRELATE WITH MATERIAL USED IN OUR MANUFACTURING PROCESS. A ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    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

    ADDITIONAL INFORMATION FROM CUSTOMER: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO. IN DESCRIPTION MENTIONED "2 DIFFERENT SYRINGES" BOTH ARE LISTED WITH THE SAME MATERIAL NUMBER (#303310). IF THEY ARE INDEED DIFFERENT, PLEASE PROVIDE THE MATERIAL NUMBERS FOR BOTH. THE SYRINGES ARE THE SAME. WAS THE SYRINGE CONNECTED TO A NEEDLE? IF YES, WAS IT A BD NEEDLE? IF IT WAS PLEASE SHARE PRODUCT INFORMATION. UNKNOWN NEEDLE TYPE. WHAT WAS USED THE SYRINGE USED FOR? IF IT WAS USED TO EXACT LIQUID FROM A VIAL, IS IT POSSIBLE THE NEEDLE CAUSED CORING? EXTRACT LOCAL ANESTHETIC FROM VIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 50 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 303310; BATCH#: 5132719. VERBATIM: 2 DIFFERENT SYRINGES HAD PARTICULATE IN THE SYRINGE PRIOR. THE PARTICLES WEREN'T PRESENT IN THE SOLUTION PRIOR TO USE AND WAS DETERMINED TO BE IN THE SYRINGE. IMAGES ARE ATTACHED BUT THE 2 FAULTY ITEMS ARE STILL IN THE CUSTOMER'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154645 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 5132719 00382903033102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown