BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS D-VIAL PREP SET

    MDR report key: 22873585 · Received August 22, 2025

    Report

    Report Number
    3005579300-2025-00016
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 25, 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
    SC, 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. A RETROSPECTIVE MDR HAS BEEN FILED DUE TO THE POTENTIAL FOR SERIOUS INJURY SHOULD THE FULL DOSE NOT BE ABLE TO BE ADMINISTERED TO THE PATIENT. 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

    PHYSICIAN WAS USING A TRINAV MICROCATHETER (.021 ID). AFTER INFUSING ABOUT 20CC OF D5W ON THE D LINE AND INFUSING CONTRAST INTERMITTENTLY IN THE B LINE, HE NOTICED FLUID WAS LEAKING FROM THE DVIAL INTO THE DVIAL HOLDER. HE DECIDED TO FINISH THE ADMINISTRATION SINCE IT WAS ALMOST FINISHED AND NOT LEAKING OUTSIDE THE DVIAL HOLDER. AFTER THE PROCEDURE THEY DETECTED NO RADIATION ANYWHERE UNINTENDED AND DISPOSED OF THE RELEVANT MATERIALS INTO A MAYO JAR. INITIAL CALCULATED ADMINISTERED ACTIVITY WAS 72%. THE RSO CAME TO THE HOSPITAL BUT DETERMINED THE ACTUAL PERCENTAGE WAS APPROXIMATELY 82%. HE SAID HE WILL NOT BE FILING A MEDICAL EVENT BUT WAS GOING TO DECIDE WHETHER HE NEEDED TO REPORT THE EVENT TO DHEC. THE MAYO JAR WAS OUT INTO STORAGE SO IT CAN BE DECAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2503652 SIROS D-VIAL PREP SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LIMITED SIR-10200 1126419 00850014612016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown