BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS DELIVERY SET

    MDR report key: 22873071 · Received August 22, 2025

    Report

    Report Number
    9710358-2025-00006
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    June 16, 2023
    Report Date
    August 22, 2025
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    IWJ
    UDI-DI
    00850014612023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVED NO THREAT TO PUBLIC HEALTH AND NO DEATH OR SERIOUS INJURY TO THE PATIENT. THE IFU HAS PRECAUTIONS FOR HANDLING RADIATION. TWO LOT NUMBERS WERE PROVIDED IN THE COMPLAINT. SIRTEX WAS UNABLE TO DETERMINE WHICH OR IF IT WAS BOTH BATCH NUMBERS THAT MALFUNCTIONED. A BATCH RECORD REVIEW WAS PERFORMED AND DID NOT RESULT IN ANY ABNORMAL FINDINGS FOR EITHER BATCH. A RETROSPECTIVE MDR WILL BE FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR SERIOUS INJURY SHOULD THE DEVICE LEAK AND THE FULL DOSE NOT BE ABLE TO BE ADMINISTERED.

    Description of Event or Problem · 0

    FOLLOWING THE COMPLETION OF THE ADMINISTRATION, A SMALL PUDDLE OF LIQUID UNDERNEATH THE "Y" CONNECTION ON THE DELIVERY SET WAS IDENTIFIED. ONCE THE MICROCATHETER, D-VIAL, AND DELIVERY SET WERE REMOVED, THE LID TO THE SIROS DOME WAS PLACED ON TOP OF THE BASE. THE SIROS DELIVERY DOME WAS THEN SURVEYED AND RESULTS CAME BACK HOT. THE SIROS DELIVERY DOME WAS THEN PLACED INTO AN APPROPRIATE DECAY LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619322 SIROS DELIVERY SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LIMITED SIR-10300 10556145, 10556146 00850014612023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown