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	Decoupling (1145)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no reported death or serious injury and it was confirmed there was no misadministration/underdose.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 due to the malfunction or potential for contamination.Though two devices were described in the event description (batch: 1126418 and 1126411), only one was returned.Sirtex was unable to determine which batch number was returned as the hospital did not provide the batch number or the packaging.Sirtex observed the tubing was separated from the valve.A supplier review of the batch records was performed.The review of batch: 1126418 revealed no abnormalities in the manufacture of the product.The review of batch: 1126411 revealed a temporary deviation was performed to inspect raw materials for blockage, remove materials that did not meet specifications, and the deviation was closed prior to the batch manufacture.
Event or Problem Description
There was some accumulation of spheres in the hub of the c-line on the d-vial during administration.The physician was pulsing on the d-line to break up the line of spheres and the tubing of the c-line on the d-vial came off the hub.Spheres were sprayed on the inside of the delivery dome; no contamination was detected outside of the dome.The delivery set and d-vial were prepped according to the ifu and the administration was performed according to the ifu.There was no misadministration/under dose.Two different lot/batch numbers were provided as this was a split dose.

• 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: 22873550
• Report Number: 3005579300-2025-00015
• Device Sequence Number: 5803382
• Product Code: IWJ
• UDI-Device Identifier: 00850014612016
• UDI-Public: (01)00850014612016(11)240425(17)250425(10)1126418
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Model Number: SIR-10200
• Device Lot Number: 1126418 AND 1126411
• 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: 07/12/2024
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown