MAUDE Adverse Event Report: SIRTEX MEDICAL PTY LIMITED SIROS DELIVERY SET; System, applicator, radionuclide, manual

Model Number	SIR-10300
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor had already delivered 20 ml of d5w through the d-line to the patient.The doctor attached another full 20 ml syringe of d5w to the d-line (to fully deliver microspheres) and with his first aliquot the d-line syringe connector broke off (with the syringe still attached) from the main d-line.Nuclear medicine was then brought into survey potential contamination.It was confirmed with there being no radioactivity on the "contaminated" towels (and further confirmed on immediate cleanup post-delivery surveys and post measurement readings).After confirming safety of the environment, the doctor simply re-attached the d-line syringe connector (with syringe still attached) to the d-line tubing and carefully delivered another 20 ml of d5w with no complications.
Additional Manufacturer Narrative
The event involved no threat to public health and no death or serious injury to the patient.A retrospective mdr has been filed out of an abundance of caution 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.

• Brand Name: SIROS DELIVERY 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: 22873536
• Report Number: 3005579300-2025-00014
• Device Sequence Number: 5803106
• Product Code: IWJ
• UDI-Device Identifier: 00850014612023
• UDI-Public: (01)00850014612023(11)240411(17)260411(10)1126415
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: 04/11/2026
• Device Model Number: SIR-10300
• Device Lot Number: 1126415
• 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: 07/11/2024
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown