BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS D-VIAL PREP SET

    MDR report key: 22873685 · Received August 22, 2025

    Report

    Report Number
    9710358-2025-00008
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    August 23, 2024
    Report Date
    August 22, 2025
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    IWJ
    UDI-DI
    00850014612016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORTED DEATH OR SERIOUS INJURY TO THE PATIENT AND THEY RECEIVED THEIR DOSE. THE MALFUNCTION CAUSED A LOSS OF THE FIRST DOSE WHICH WAS REDRAWN AND DELIVERED. A RETROSPECTIVE MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR SERIOUS INJURY DUE TO THE POTENTIAL FOR RADIOACTIVE CONTAMINATION AND SHOULD THE FULL DOSE NOT BE ABLE TO BE ADMINISTERED TO THE PATIENT. THE DEVICE WAS RETURNED TO SIRTEX AND THE SEPARATED TUBING FROM THE VALVE WAS OBSERVED. A BATCH RECORD REVIEW WAS PERFORMED AND DID NOT DISPLAY ANYTHING ABNORMAL FOR THE MANUFACTURING PROCESS AND ALL OPERATIONS WERE COMPLETED PER PROCEDURES.

    Description of Event or Problem · 0

    THE VALVE WHICH CONNECTS TO THE C-LINE FROM THE D-VIAL DISCONNECTED DURING THE FIRST ALIQUOT OF SIR-SPHERES ADMINISTRATION. THE TUBING DID NOT RUPTURE, IT SIMPLY DISCONNECTED FROM THE VALVE ON THE C-LINE COMING OFF THE D-VIAL. THE C TO C CONNECTION REMAINED IN TACT. THIS RESULTED IN A SPILL WITHIN THE SIROS DELIVERY DOME. THE SPILL WAS CONTAINED BUT THIS WAS A FAILURE OF THE C LINE VALVE AND C LINE TUBING OF THE D-VIAL PREP SET. THE DOSE WAS UNABLE TO BE ADMINISTERED. DURING THE SCHEDULED OPERATION, NUCLEAR MEDICINE PREPARED ANOTHER DOSE, PATIENT RECEIVED APPROPRIATE PRESCRIBED DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2456110 SIROS D-VIAL PREP SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LIMITED SIR-10200 1126425 00850014612016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown