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	Contamination (1120)
Health Effect - Clinical Code	Restless Legs Syndrome (4584)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When injecting df5 back into the d-vial, a black particulate floated up.
Additional Manufacturer Narrative
There was no death or serious injury reported.In follow up correspondence, it was learned that the dose was redrawn and a new d-vial set was used.A batch record review was performed and did not display anything abnormal for the manufacturing process.The device was not returned for further investigation.The catheter diameter and in-line filters would prevent such fragments from reaching the patient.A retrospective mdr has been filed out of an abundance of caution as the particulate or its origin could not be determined.

• Brand Name: SIROS D-VIAL PREP SET
• Common Device Name: System, applicator, radionuclide, manual
• Manufacturer (Section D): SIRTEX MEDICAL PTY LIMITED; 207 pacific highway; st. leonards 2065 ; AS 2065
• Manufacturer Contact: melissa sanchez ; 300 unicorn park; floor 2; woburn, MA 01801
• MDR Report Key: 22873510
• Report Number: 3005579300-2025-00012
• Device Sequence Number: 17586425
• Product Code: IWJ
• UDI-Device Identifier: 00850014612016
• UDI-Public: (01)00850014612016(11)240227(17)250227(10)1126403
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2025
• Device Model Number: SIR-10200
• Device Lot Number: 1126403
• 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: 05/23/2024
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2024
• 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