BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS DELIVERY SET

    MDR report key: 22873226 · Received August 22, 2025

    Report

    Report Number
    3005579300-2025-00008
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    September 20, 2023
    Manufacturer
    SIRTEX MEDICAL PTY LTD
    Product Code
    IWJ
    UDI-DI
    00850014612023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEATH, SERIOUS INJURY, OR OTHER SERIOUS ADVERSE EVENTS WERE REPORTED. THE IFU HAS PRECAUTIONS FOR HANDLING RADIATION. THE BATCH RECORD REVIEW WAS FOUND TO BE MANUFACTURED ACCORDANCE WITH THE APPROVED SPECIFICATIONS. THE DEVICE WAS RETURNED TO SIRTEX FOR INVESTIGATION AND WAS REPLICATED AND DESCRIBED IN THE REPORT AS LIKELY DUE TO A POOR GLUE JOINT AT THE A LINE CONNECTION. 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

    THE DELIVERY SET WAS FLUSHED ACCORDING TO IFU PRIOR TO STARTING THE ADMINISTRATION. AFTER THE 2ND ALIQUOT, THE DELIVERY SET STARTED LEAKING WHERE THE A LINE COMES OUT OF THE "Y" INTERSECTION. A POOLING OF LIQUID THE SIZE OF A QUARTER WAS OBSERVED. WE STOPPED THE ADMINISTRATION AND HAD TO RE-DRAW THE DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666884 SIROS DELIVERY SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LTD SIR-10300 10556145 00850014612023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown