BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS D-VIAL PREP SET

    MDR report key: 22873550 · Received August 22, 2025

    Report

    Report Number
    3005579300-2025-00015
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 11, 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORTED DEATH OR SERIOUS INJURY AND IT WAS CONFIRMED THERE WAS NO MISADMINISTRATION/UNDERDOSE. 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 DUE TO THE MALFUNCTION OR POTENTIAL FOR CONTAMINATION. THOUGH TWO DEVICES WERE DESCRIBED IN THE EVENT DESCRIPTION (BATCH: 1126418 AND 1126411), ONLY ONE WAS RETURNED. SIRTEX WAS UNABLE TO DETERMINE WHICH BATCH NUMBER WAS RETURNED AS THE HOSPITAL DID NOT PROVIDE THE BATCH NUMBER OR THE PACKAGING. SIRTEX OBSERVED THE TUBING WAS SEPARATED FROM THE VALVE. A SUPPLIER REVIEW OF THE BATCH RECORDS WAS PERFORMED. THE REVIEW OF BATCH: 1126418 REVEALED NO ABNORMALITIES IN THE MANUFACTURE OF THE PRODUCT. THE REVIEW OF BATCH: 1126411 REVEALED A TEMPORARY DEVIATION WAS PERFORMED TO INSPECT RAW MATERIALS FOR BLOCKAGE, REMOVE MATERIALS THAT DID NOT MEET SPECIFICATIONS, AND THE DEVIATION WAS CLOSED PRIOR TO THE BATCH MANUFACTURE.

    Description of Event or Problem · 0

    THERE WAS SOME ACCUMULATION OF SPHERES IN THE HUB OF THE C-LINE ON THE D-VIAL DURING ADMINISTRATION. THE PHYSICIAN WAS PULSING ON THE D-LINE TO BREAK UP THE LINE OF SPHERES AND THE TUBING OF THE C-LINE ON THE D-VIAL CAME OFF THE HUB. SPHERES WERE SPRAYED ON THE INSIDE OF THE DELIVERY DOME; NO CONTAMINATION WAS DETECTED OUTSIDE OF THE DOME. THE DELIVERY SET AND D-VIAL WERE PREPPED ACCORDING TO THE IFU AND THE ADMINISTRATION WAS PERFORMED ACCORDING TO THE IFU. THERE WAS NO MISADMINISTRATION/UNDER DOSE. TWO DIFFERENT LOT/BATCH NUMBERS WERE PROVIDED AS THIS WAS A SPLIT DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619348 SIROS D-VIAL PREP SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LIMITED SIR-10200 1126418 AND 1126411 00850014612016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown