BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS D-VIAL PREP SET

    MDR report key: 24022841 · Received January 9, 2026

    Report

    Report Number
    3009088444-2026-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 11, 2025
    Report Date
    March 11, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    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

    THERE WAS NO REPORTED DEATH OR SERIOUS INJURY TO THE PATIENT AND THEY RECEIVED THEIR DOSE. SIRTEX HAS LEARNED THAT A NEW D-VIAL WAS USED FOR THE DELIVERY OF THE SECOND PREPARED DOSE. THIS 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 REVIEW OF PRODUCTION RECORDS SHOW THE BATCH WAS MANUFACTURED TO APPROVED SPECIFICATIONS AND MET ALL QUALITY ASSURANCE CRITERIA. EACH UNIT IS SUBJECT TO A 100% LEAK TEST INSPECTION PER THE SUPPLIER'S PROCEDURE. THE DEVICE WAS RETURNED AND FUNCTIONALLY TESTED BY SIRTEX. THE EVENT WAS NOT REPLICATED AS NO LEAK WAS OBSERVED. SIRTEX MEDICAL AFFAIRS HAS ALSO STATED FROM A MEDICAL PERSPECTIVE, THIS EVENT DOES NOT REPRESENT A PATIENT ADVERSE EVENT BUT RATHER A DEVICE-RELATED MALFUNCTION WITHOUT PATIENT HARM. THE TEMPORARY UNDER-DELIVERY OF DOSE WAS PROMPTLY RECOGNIZED AND MITIGATED, AND THERE IS NO INDICATION OF INCREASED SAFETY RISK OR NEGATIVE IMPACT ON PATIENT OUTCOME. THE OVERALL BENEFIT/RISK PROFILE REMAINS FAVORABLE, AND NO ADDITIONAL PATIENT-LEVEL MEDICAL INTERVENTION OR FOLLOW-UP IS WARRANTED BASED ON THE INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING AND AN UPDATE WILL BE PROVIDED ON THE NEXT REPORT.

    Description of Event or Problem · 0

    DURING THE DOSE DELIVERY, A LEAK WAS OBSERVED FROM THE D-VIAL. THREE ALIQUOTS OF THE DOSE WERE ATTEMPTED AND THE PATIENT RECEIVED ~65% OF THE DOSE. THE LEAK WAS CONTAINED WITHIN THE D-VIAL HOLDER AND NO CONTAMINATION OCCURRED. THE PHARMACY WAS CALLED AND PROVIDED A SECOND DOSE AND THE SECOND DELIVERY WAS ACHIEVED WITH NO FURTHER INCIDENT.

    Description of Event or Problem · 0

    DURING THE DOSE DELIVERY, A LEAK WAS OBSERVED FROM THE D-VIAL. THREE ALIQUOTS OF THE DOSE WERE ATTEMPTED AND THE PATIENT RECEIVED ~65% OF THE DOSE. THE LEAK WAS CONTAINED WITHIN THE D-VIAL HOLDER AND NO CONTAMINATION OCCURRED. THE PHARMACY WAS CALLED AND PROVIDED A SECOND DOSE AND THE SECOND DELIVERY WAS ACHIEVED WITH NO FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80689 SIROS D-VIAL PREP SET SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL IWJ SIRTEX MEDICAL, INC. SIR-10200 1142842 00850014612016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown