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	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• 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; floor 2; woburn, MA 01801
• MDR Report Key: 22873609
• Report Number: 3005579300-2025-00017
• Device Sequence Number: 17564797
• Product Code: IWJ
• UDI-Device Identifier: 00850014612016
• UDI-Public: (01)00850014612016(11)240108(17)250108(10)1109060
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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 Expiration Date: 01/08/2025
• Device Model Number: SIR-10200
• Device Lot Number: 1109060
• 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: 08/26/2024
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• 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