BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS D-VIAL PREP SET

    MDR report key: 22873609 · Received August 22, 2025

    Report

    Report Number
    3005579300-2025-00017
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    August 19, 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
    TN, 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. A RETROSPECTIVE MDR HAS BEEN FILED DUE TO THE POTENTIAL FOR SERIOUS INJURY DUE TO THE POTENTIAL OF RADIOACTIVE CONTAMINATION OR SHOULD THE FULL DOSE NOT BE ABLE TO BE ADMINISTERED TO THE PATIENT. A BATCH RECORD REVIEW WAS PERFORMED AND DID NOT DISPLAY ANYTHING ABNORMAL FOR THE MANUFACTURING PROCESS AND ALL OPERATIONS WERE COMPLETED PER PROCEDURES.

    Description of Event or Problem · 0

    THE VALVE ON THE D-VIAL D-LINE WAS NOT CORRECTLY GLUED INTO PLACE AND DISCONNECTED FROM THE D-VIAL D-LINE TUBE. THE DISCONNECTION OCCURRED AFTER 30 ML HAD BEEN INFUSED TO THE PATIENT. PATIENT ENDED UP RECEIVING 96% OF THE DRAWN DOSE, HOWEVER THE DELIVERY DOME WAS CONTAMINATED AND HAD TO BE PLACED IN DECAYED STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2656941 SIROS D-VIAL PREP SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LIMITED SIR-10200 1109060 00850014612016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown