BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS D-VIAL PREP SET

    MDR report key: 24445039 · Received February 25, 2026

    Report

    Report Number
    9710358-2026-00003
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 25, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    IWJ
    UDI-DI
    00850014612016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING AND AN UPDATE WILL BE PROVIDED ON THE NEXT REPORT.

    Description of Event or Problem · 0

    DURING THE ADMINISTRATION OF SIR-SPHERES, THE TOP OF THE D-VIAL STARTED LEAKING. THIS WAS OBSERVED AFTER THE FIRST ALIQUOT OF THE DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292470 SIROS D-VIAL PREP SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL, INC. SIR-10200 11428139 00850014612016

    Patients

    Seq Age Sex Outcome Treatment
    1