BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS D-VIAL PREP SET

    MDR report key: 22873510 · Received August 22, 2025

    Report

    Report Number
    3005579300-2025-00012
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    May 23, 2024
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    IWJ
    UDI-DI
    00850014612016
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEATH OR SERIOUS INJURY REPORTED. IN FOLLOW UP CORRESPONDENCE, IT WAS LEARNED THAT THE DOSE WAS REDRAWN AND A NEW D-VIAL SET WAS USED. A BATCH RECORD REVIEW WAS PERFORMED AND DID NOT DISPLAY ANYTHING ABNORMAL FOR THE MANUFACTURING PROCESS. THE DEVICE WAS NOT RETURNED FOR FURTHER INVESTIGATION. THE CATHETER DIAMETER AND IN-LINE FILTERS WOULD PREVENT SUCH FRAGMENTS FROM REACHING THE PATIENT. 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

    WHEN INJECTING DF5 BACK INTO THE D-VIAL, A BLACK PARTICULATE FLOATED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558443 SIROS D-VIAL PREP SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LIMITED SIR-10200 1126403 00850014612016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown