BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS DELIVERY SET

    MDR report key: 22873186 · Received August 22, 2025

    Report

    Report Number
    9710358-2025-00007
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    August 11, 2023
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    IWJ
    UDI-DI
    00850014612023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEAK WAS FOUND UNDER THE LID OF THE DELIVERY DOME, SO THE RADIATION WAS SHIELDED. THE IFU HAS PRE-CAUTIONS FOR HANDLING RADIATION. THE DEVICE WAS RETURNED TO SIRTEX FOR INVESTIGATION BUT THE EVENT WAS NOT REPLICATED. THE DHR REVIEW DID NOT DISPLAY ANY ABNORMAL FINDINGS FOR THE MANUFACTURING PROCESS AND ALL OPERATIONS WERE COMPLETED PER PROCEDURES. IT WAS STATED THAT THE PATIENT RECEIVED THEIR DOSE. A RETROSPECTIVE MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR SERIOUS INJURY SHOULD THE FULL DOSE NOT BE ABLE TO BE ADMINISTERED.

    Description of Event or Problem · 0

    A SMALL POOL OF ACTIVITY WAS IDENTIFIED ON "THE" BASE OF THE DELIVERY DOME (UNDER THE LID ON THE CLEAR ACRYLIC) AT THE END OF TREATMENT. THE POOL OF LIQUID WAS LOCATED UNDER THE C LINE CONNECTION. NO DRIPS COMING FROM THE CONNECTION WERE OBSERVED DURING DELIVERY. IR DID NOT HAVE ANY ISSUES WITH CONNECTION. C LINE WAS NOT DISCONNECTED AFTER TREATMENT. GLOVES WERE NOT HOT. THE SPILL WAS CLEANED AND CONTAINED. THE SIROS DOME WAS SENT TO DECAY. D VIAL AND DELIVERY SET WERE MARKED TO BE INSPECTED AFTER DECAY. 96% OF DOSE DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395922 SIROS DELIVERY SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LIMITED SIR-10300 10556133 00850014612023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown