BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 24776490 · Received April 3, 2026

    Report

    Report Number
    1213809-2026-00174
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 10, 2026
    Report Date
    May 22, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095750
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 21X1 RB HAD LEAKAGE PAST THE STOPPER. VERBATIM: COMPLAINT VIA EMAIL. EARLIER TODAY, ONE OF MY DISPENSERS NOTICED THAT THEIR SYRINGE WAS LEAKING DOWN THE PLUNGER AND HAD LEAKED THROUGH THE RUBBER STOPPER PIECE. I HAVE ATTACHED THE IMAGES. IT IS LITTLE DIFFICULT TO TELL AS THE DISPENSERS MUST USE A SYRINGE SHIELD, BUT THE LIQUID IS FAINTLY VISIBLE WITHIN THE SHIELD. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY: (B)(6) 2026. CAN YOU PLEASE PROVIDE THE MATERIAL AND LOT NUMBER ASSOCIATED WITH REPORTED ISSUE: MATERIAL NUMBER - 309575, LOT # - 5241754. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL: NO, THE DEFECT WAS FOUND ON THE SYRINGE WHILE FILLING A DOSE. - THE SYRINGE IS CONTAMINATED. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT: SLOWED DOWN PRODUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21673 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5241754 30382903095750

    Patients

    Seq Age Sex Outcome Treatment
    1