BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS DELIVERY SET

    MDR report key: 24681209 · Received March 24, 2026

    Report

    Report Number
    9710358-2026-00009
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 24, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    IWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    PRIOR TO THE ADMINISTRATION, DURING THE SET-UP PROCESS, THE PHYSICIAN CRACKED THE D LINE CONNECTION THAT ATTACHES TO THE D VIAL. A NEW D LINE WAS TAKEN FROM A NEW DELIVERY SET, PRIMED AND CONNECTED AS NORMAL. HALFWAY THROUGH THE DELIVERY IT WAS NOTICED THAT A COLUMN OF WATER WAS FORMING OUTSIDE OF THE D-VIAL BUT WAS CONTAINED IN THE ACRYLIC SHIELDING OF THE VIAL. THERE WAS NO VORTEX FORMING TO SUSPEND THE SPHERES AND D5W WAS STILL ABLE TO BE PUSHED THROUGH AND OUT OF THE MICRO CATHETER. THERE WAS NO ISSUE PUSHING CONTRAST THROUGH THE B LINE. IT WAS STATED THAT A 20CC SYRINGE WAS USED ON D LINE, A 10CC SYRINGE USED ON B LINE, AND A .021 MICRO CATHETER WAS USED DURING ADMINISTRATION. NO CLUMPING OF SPHERES WAS OBSERVED IN THE D VIAL OR IN THE COLUMN OF WATER. IT WAS STATED THAT 94% OF DOSE WAS ADMINISTERED TO PATIENT AND THAT THE DEVICE WOULD BE RETURNED AFTER THE DECAY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739847 SIROS DELIVERY SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL, INC. SIR-10300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown