BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL PRECISE

    MDR report key: 23392134 · Received October 27, 2025

    Report

    Report Number
    2243072-2025-01301
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 21, 2025
    Report Date
    October 29, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUES OF FOREIGN MATTER AND STOPPER DEFECTIVE/ DAMAGED WERE CONFIRMED UPON INSPECTION OF THE PHOTOS. HOWEVER, THE ROOT CAUSE FOR THE FOREIGN MATTER COULD NOT BE DETERMINED WITHOUT THE PHYSICAL SAMPLE. FROM THE PHOTO EVALUATION, THE TEAM OBSERVED POOR ASSEMBLY BETWEEN THE STOPPER AND PLUNGER. THE ROOT CAUSE IS THE STOPPER NOT PROPERLY BEING SEATED ON THE LOWER TOOLING RESULTING IN THE NON-CONFORMANCE. THERE IS A VISION SYSTEM AT THE ASSEMBLY MACHINE THAT CAN DETECT AND AUTO-REJECT THIS DEFECT. THE 50 ML MACHINE HAS BEEN OBSOLETED; SO, NO FURTHER ACTION CAN BE TAKEN. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    CUSTOMER HAS FOUND TWO FAULTY 50ML PRECISE SYRINGES, AS SHOWN IN THE ATTACHED PHOTOS (LOT NUMBER: 2141789). ONE SYRINGE HAD A RUBBER PLUNGER THAT DIDN'T SIT FLAT, AND THE OTHER APPEARED TO HAVE SOMETHING (WHITE COLOUR) INSIDE THE RUBBER, WE NOTICED IT AFTER DRAWING UP SODIUM CHLORIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2793734 SYRINGE 50ML LL PRECISE PISTON SYRINGE FMF BECTON DICKINSON 2141789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown