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	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The valve which connects to the c-line from the d-vial disconnected during the first aliquot of sir-spheres administration.The tubing did not rupture, it simply disconnected from the valve on the c-line coming off the d-vial.The c to c connection remained in tact.This resulted in a spill within the siros delivery dome.The spill was contained but this was a failure of the c line valve and c line tubing of the d-vial prep set.The dose was unable to be administered.During the scheduled operation, nuclear medicine prepared another dose, patient received appropriate prescribed dose.
Additional Manufacturer Narrative
There was no reported death or serious injury to the patient and they received their dose.The malfunction caused a loss of the first dose which was redrawn and delivered.A retrospective mdr has been filed out of an abundance of caution due to the potential for serious injury due to the potential for radioactive contamination and should the full dose not be able to be administered to the patient.The device was returned to sirtex and the separated tubing from the valve was observed.A batch record review was performed and did not display anything abnormal for the manufacturing process and all operations were completed per procedures.

• 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: 22873685
• Report Number: 9710358-2025-00008
• Device Sequence Number: 21438638
• Product Code: IWJ
• UDI-Device Identifier: 00850014612016
• UDI-Public: (01)00850014612016(11)240522(17)250522(10)1126425
• 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): N
• 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: 05/22/2025
• Device Model Number: SIR-10200
• Device Lot Number: 1126425
• Was Device Available for Evaluation?: Yes
• 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): Yes
• Date Device Manufactured: 05/22/2024
• 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