BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 24604932 · Received March 16, 2026

    Report

    Report Number
    1213809-2026-00120
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    January 8, 2026
    Report Date
    April 3, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED, AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. BATCH 2103602 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. THE COMPLAINT WAS NOT CONFIRMED, AND NO CAPA EVALUATION WAS REQUIRED. THIS COMPLAINT TYPE WILL CONTINUE TO BE TRENDED WITHIN THE POST-MARKET SURVEILLANCE PROCESS, AND ANY DETERMINED ESCALATION WILL BE MANAGED THERE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C BARREL CRACKED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE 3ML SYRINGE THAT WAS GOING TO BE USED TO GIVE IM (INTRAMUSCULAR) MEDICATION STARTED LEAKING FROM CRACK IN THE MIDDLE OF SYRINGE. COULD YOU CONFIRM THE CRACK WAS ON THE CLEAR PLASTIC CYLINDER (THE BARREL) RATHER THAN AT THE TIP WHERE THE NEEDLE ATTACHES? THE CRACK WAS ON THE PLASTIC CYLINDER, NOT AT THE TIP.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361161 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2103602 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other