BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS D-VIAL PREP SET

    MDR report key: 25279018 · Received May 26, 2026

    Report

    Report Number
    3005579300-2026-00001
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 26, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    IWJ
    UDI-DI
    00850014612016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE-RELATED DEATH OR SERIOUS INJURY WAS REPORTED AND IT WAS STATED THAT THE PATIENT WAS TREATED SUCCESSFULLY. THE IFU ALSO STATES TO ENSURE NO AIR IS IN THE LINES. SIRTEX IS WORKING WITH THE THIRD PARTY PHARMACY TO RESOLVE THE ISSUE. SIRTEX MEDICAL AFFAIRS HAS ASSESSED THIS EVENT AS MOST CONSISTENT WITH A PREPARATION AND HANDLING-RELATED ISSUE ASSOCIATED WITH THIRD-PARTY PHARMACY DOSE PREPARATION RATHER THAN AN INTRINSIC MALFUNCTION OF THE SIROS D-VIAL PREP SET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT INJURY, ADVERSE CLINICAL SEQUELAE, OR MEANINGFUL IMPACT TO TREATMENT DELIVERY. THE REPORTED PRESENCE OF AIR WITHIN THE LINE IS A KNOWN HANDLING CONSIDERATION ADDRESSED WITHIN THE IFU, AND THE RECURRENCE AT THE SAME SITE SUPPORTS REINFORCEMENT OF PROPER PREPARATION AND PRIMING PROCEDURES. OVERALL, THE BENEFIT-RISK PROFILE OF THE DEVICE REMAINS UNCHANGED.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED STATING MULTIPLE OCCASIONS OF AIR BEING INTRODUCED TO THE DELIVERY SET VIA THE PREPARED DOSE FROM THE D-VIAL. THE DOSE IS PREPARED BY A THIRD PARTY PHARMACY WHICH IS THEN PROVIDED TO THE HOSPITAL. THE HOSPITAL USED A SYRINGE TO REMOVE THE AIR BUBBLE AND BECAME RADIOACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407818 SIROS D-VIAL PREP SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL, INC. SIR-10200 00850014612016

    Patients

    Seq Age Sex Outcome Treatment
    1