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	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Physician was using a trinav microcatheter (.021 id).After infusing about 20cc of d5w on the d line and infusing contrast intermittently in the b line, he noticed fluid was leaking from the dvial into the dvial holder.He decided to finish the administration since it was almost finished and not leaking outside the dvial holder.After the procedure they detected no radiation anywhere unintended and disposed of the relevant materials into a mayo jar.Initial calculated administered activity was 72%.The rso came to the hospital but determined the actual percentage was approximately 82%.He said he will not be filing a medical event but was going to decide whether he needed to report the event to dhec.The mayo jar was out into storage so it can be decayed.
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 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.

• 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: 22873585
• Report Number: 3005579300-2025-00016
• Device Sequence Number: 17565163
• Product Code: IWJ
• UDI-Device Identifier: 00850014612016
• UDI-Public: (01)00850014612016(11)240425(17)250425(10)1126419
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: 04/25/2025
• Device Model Number: SIR-10200
• Device Lot Number: 1126419
• 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: 07/25/2024
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2024
• 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