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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
At the very end of the procedure, while flushing through the d-line a few droplets of d5w were noticed escaping through the septum of the d-vial and rolling over the edge.Nothing escaped the siros system and after surveying and conducting the post procedure measurements there was almost no residual and over 100% of the written directive was delivered.Whatever malfunction occurred it didn't happen until we were done delivering the y90 spheres but had this happened earlier in the procedure it may have been a different story.I took a short video of the incident to better explain what happened and can provide it if necessary.
Additional Manufacturer Narrative
There was no reported death or serious injury to the patient and they received their full dose.The device was returned to sirtex for investigation and the event was not replicated.A batch record review was performed and no discrepancies were found.A retrospective mdr has been filed out of an abundance of caution due to the potential for serious injury should the full dose not be able to be administered.

• 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: 22873293
• Report Number: 3005579300-2025-00009
• Device Sequence Number: 5803103
• Product Code: IWJ
• UDI-Device Identifier: 00850014612016
• UDI-Public: (01)00850014612016(11)230726(17)240726(10)1109047
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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

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: 07/26/2024
• Device Model Number: SIR-10200
• Device Lot Number: 1109047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• 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: 12/15/2023
• Initial Report FDA Received Date: 08/22/2025
• Date Device Manufactured: 07/26/2023
• 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