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

Model Number	SIR-10300
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No death, serious injury, or other serious adverse events were reported.The ifu has precautions for handling radiation.The batch record review was found to be manufactured accordance with the approved specifications.The device was returned to sirtex for investigation and was replicated and described in the report as likely due to a poor glue joint at the a line connection.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.
Event or Problem Description
The delivery set was flushed according to ifu prior to starting the administration.After the 2nd aliquot, the delivery set started leaking where the a line comes out of the "y" intersection.A pooling of liquid the size of a quarter was observed.We stopped the administration and had to re-draw the dose.

• Brand Name: SIROS DELIVERY SET
• Common Device Name: System, applicator, radionuclide, manual
• Manufacturer (Section D): SIRTEX MEDICAL PTY LTD; 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: 22873226
• Report Number: 3005579300-2025-00008
• Device Sequence Number: 13354933
• Product Code: IWJ
• UDI-Device Identifier: 00850014612023
• UDI-Public: (01)00850014612023(11)221129(17)241129(10)10556145
• 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: Other Health Care Professional
• 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: 11/29/2024
• Device Model Number: SIR-10300
• Device Lot Number: 10556145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• 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: 09/20/2023
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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