MAUDE Adverse Event Report: SIRTEX MEDICAL PTY LIMITED SIROS D-VIAL PREP SET; System, applicator, radionuclide, manual

Model Number	SIR-10200
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No death or serious injury were reported and it was stated that the patient was treated without issue.The ifus state to ensure air is removed from the lines and specifically to fill the d-vial to the fill level mark and to ensure the wet to wet connection on the c-lines to prevent air from being introduced.A follow-up meeting was held with the third-party pharmacy and they stated that they flushed/primed the system per instructions in the ifu.A review of production records shows the batch was manufactured to approved specifications and met all quality assurance criteria.This mdr has been filed due to the potential for serious injury as there is a potential risk of air embolism should the lines not be properly flushed.
Event or Problem Description
A third-party pharmacy was used to prepare the dose for the hospital.The hospital has stated they experienced two incidences of air coming out of the c line off the d-vial during the procedure.

• Brand Name: SIROS D-VIAL PREP SET
• Common Device Name: System, applicator, radionuclide, manual
• Manufacturer (Section D): SIRTEX MEDICAL PTY LIMITED; 207 pacific highway; shop 6; st. leonards 2065 ; AS 2065
• Manufacturer Contact: melissa sanchez ; 300 unicorn park drive; floor 2; woburn, MA 01801
• MDR Report Key: 23380761
• Report Number: 9710358-2025-00014
• Device Sequence Number: 9090877
• Product Code: IWJ
• UDI-Device Identifier: 00850014612016
• UDI-Public: (01)00850014612016(11)250620(17)270620(10)1142842
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIR-10200
• Device Lot Number: 1142842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown