BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS D-VIAL PREP SET

    MDR report key: 23380761 · Received October 24, 2025

    Report

    Report Number
    9710358-2025-00014
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 24, 2025
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    IWJ
    UDI-DI
    00850014612016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEATH OR SERIOUS INJURY WERE REPORTED AND IT WAS STATED THAT THE PATIENT WAS TREATED WITHOUT ISSUE. THE IFUS STATE TO ENSURE AIR IS REMOVED FROM THE LINES AND SPECIFICALLY TO FILL THE D-VIAL TO THE FILL LEVEL MARK AND TO ENSURE THE WET TO WET CONNECTION ON THE C-LINES TO PREVENT AIR FROM BEING INTRODUCED. A FOLLOW-UP MEETING WAS HELD WITH THE THIRD-PARTY PHARMACY AND THEY STATED THAT THEY FLUSHED/PRIMED THE SYSTEM PER INSTRUCTIONS IN THE IFU. A REVIEW OF PRODUCTION RECORDS SHOWS THE BATCH WAS MANUFACTURED TO APPROVED SPECIFICATIONS AND MET ALL QUALITY ASSURANCE CRITERIA. THIS MDR HAS BEEN FILED DUE TO THE POTENTIAL FOR SERIOUS INJURY AS THERE IS A POTENTIAL RISK OF AIR EMBOLISM SHOULD THE LINES NOT BE PROPERLY FLUSHED.

    Description of Event or Problem · 0

    A THIRD-PARTY PHARMACY WAS USED TO PREPARE THE DOSE FOR THE HOSPITAL. THE HOSPITAL HAS STATED THEY EXPERIENCED TWO INCIDENCES OF AIR COMING OUT OF THE C LINE OFF THE D-VIAL DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612213 SIROS D-VIAL PREP SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LIMITED SIR-10200 1142842 00850014612016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown