BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 24079419 · Received January 15, 2026

    Report

    Report Number
    2243072-2025-01583
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 16, 2025
    Report Date
    January 20, 2026
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    AS NO PHYSICAL OR PICTURE SAMPLE, OR VALID LOT NUMBER WAS PROVIDED FOR EVALUATION, BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REFERENCE: (B)(4) BATCH NUMBER: 2504028 DATE OF OCCURRENCE: (B)(6) 2025 DESCRIPTION OF THE INCIDENT: THE 20CC AND 10CC SYRINGES DO NOT DRAW UP THE AMOUNT DISPLAYED. 9CC DRAWN UP CORRESPONDS TO 10CC IN THE SYRINGE. 18CC DRAWN CORRESPONDS TO 20CC IN THE SYRINGE. CURRENT PATIENT STATUS: NR ACTIONS TAKEN IN THE HEALTHCARE FACILITY TO TREAT THE PATIENT: NR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354287 BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown