BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS D-VIAL PREP SET

    MDR report key: 22873373 · Received August 22, 2025

    Report

    Report Number
    3005579300-2025-00010
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    December 22, 2023
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    IWJ
    UDI-DI
    00850014612016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH RECORD REVIEW WAS PERFORMED AND DID NOT DISPLAY ANYTHING ABNORMAL FOR THE MANUFACTURING PROCESS AND ALL OPERATIONS WERE COMPLETED PER PROCEDURES. A GREEN COMPONENT IS PART OF THE DEVICE AND FOUND AT THE END OF THE C LINE CONNECTED TO THE D VIAL. THE DEVICE WAS NOT RETURNED SO NO ADDITIONAL INVESTIGATION COULD BE PERFORMED ON THE PARTICULATE. THE CATHETER DIAMETER AND IN-LINE FILTERS WOULD PREVENT SUCH A FRAGMENT FROM REACHING THE PATIENT. THERE WAS NO REPORTED DEATH OR SERIOUS INJURY TO THE PATIENT AND THEY RECEIVED THEIR DOSE. A RETROSPECTIVE MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION AS THE PARTICULATE OR ITS ORIGIN COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    DURING A SIROS DELIVERY THE PHYSICIAN NOTICED A PIECE OF SOMETHING IN THE D VIAL. THE PIECE APPEARED TO BE A GREEN COLOR. THE DELIVERY WAS STOPPED, THE SYSTEM DISCONNECTED AND PUT IN A MAYO JAR. THE PROCEDURE WAS SUCCESSFUL (PATIENT UNAFFECTED) AND WAS STOPPED WITH 85% OF THE PRODUCT DELIVERED. PICTURES WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2656935 SIROS D-VIAL PREP SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LIMITED SIR-10200 1109049 00850014612016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown