BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS D-VIAL PREP SET

    MDR report key: 22873293 · Received August 22, 2025

    Report

    Report Number
    3005579300-2025-00009
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    December 14, 2023
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    IWJ
    UDI-DI
    00850014612016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 FULL DOSE. THE DEVICE WAS RETURNED TO SIRTEX FOR INVESTIGATION AND THE EVENT WAS NOT REPLICATED. A BATCH RECORD REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE FOUND. 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

    AT THE VERY END OF THE PROCEDURE, WHILE FLUSHING THROUGH THE D-LINE A FEW DROPLETS OF D5W WERE NOTICED ESCAPING THROUGH THE SEPTUM OF THE D-VIAL AND ROLLING OVER THE EDGE. NOTHING ESCAPED THE SIROS SYSTEM AND AFTER SURVEYING AND CONDUCTING THE POST PROCEDURE MEASUREMENTS THERE WAS ALMOST NO RESIDUAL AND OVER 100% OF THE WRITTEN DIRECTIVE WAS DELIVERED. WHATEVER MALFUNCTION OCCURRED IT DIDN'T HAPPEN UNTIL WE WERE DONE DELIVERING THE Y90 SPHERES BUT HAD THIS HAPPENED EARLIER IN THE PROCEDURE IT MAY HAVE BEEN A DIFFERENT STORY. I TOOK A SHORT VIDEO OF THE INCIDENT TO BETTER EXPLAIN WHAT HAPPENED AND CAN PROVIDE IT IF NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2618796 SIROS D-VIAL PREP SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LIMITED SIR-10200 1109047 00850014612016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown