BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL

    MDR report key: 23291267 · Received October 15, 2025

    Report

    Report Number
    2243072-2025-01247
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    October 3, 2025
    Report Date
    October 22, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    ON (B)(6) 2025 TO REPORT ANOTHER 1 MITOMYCIN SYRINGE WITH BLACK PLASTIC FLECKS IN THE SOLUTION (CODE 302113, BATCH 4200166). CUSTOMER REPORTED THEY HAVE NOW HAD 2 KNOWN MMC SYRINGES INCLUDING BLACK PLASTIC FLECKS IN THE SOLUTION (REFER TO (B)(4) FOR EARLIER COMPLAINT). CUSTOMER REPORTED THIS LATEST EVENT WAS IDENTIFIED THAT DAY, PRODUCT IS UNOPENED AND UNUSED. CUSTOMER REPORTED THAT SINCE THE PRODUCT WAS DELIVERED ON 12 SEP 2025, IT HAS BEEN STORED IN THE FREEZER. THIS WAS IDENTIFIED AT THE CENTRE, PRIOR TO USE. CUSTOMER FORWARDED A VIDEO; HOWEVER, IT IS ONLY AUDIO. STATUS OF THE ACTUAL SAMPLE / PHOTOGRAPHS HAVE BEEN REQUESTED FOR INVESTIGATION. BAXTER COMPOUNDING SERVICES PRODUCT: MITOMYCIN EO (OMEGAPHARM) 0.4MG IN BALANCED SALT SOLUTION SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149203 SYRINGE 3ML LL PISTON SYRINGE FMF BECTON DICKINSON 4200166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown