BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL EURO 125 S/C

    MDR report key: 24406789 · Received February 20, 2026

    Report

    Report Number
    1213809-2026-00087
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    February 2, 2026
    Report Date
    March 9, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096497
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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.

    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. 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 5ML LL EURO 125 S/C BARREL WAS CRACKED. VERBATIM: "DURING THE PREPARATION OF CHEMOTHERAPIES IN THE INJECTABLE RECONSTITUTION UNIT AT THE PUI, WE NOTICED VISIBLE CRACKS ON 2 SYRINGES OF DIFFERENT SIZES AND LOTS. THIS COULD LEAD TO CYTOTOXIC CONTAMINATION OF THE WORKING ENVIRONMENT AND PERSONNEL (EVEN THOUGH THE RISK IS MINIMAL AS HANDLING OCCURS UNDER AN ISOLATOR) AND PRODUCT LOSS." THE CRACK WAS ALONG THE BODY OF THE SYRINGE FOR BOTH REFERENCES (B)(4). WHEN THE PERSON PUSHED THE PLUNGER, PRODUCT CAME OUT THROUGH THE CRACK.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150442 BD SYRINGE 5ML LL EURO 125 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3206659 00382903096497

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other