MAUDE Adverse Event Report: Sirtex Medical, Inc. SIROS D-Vial Prep Set; Shield, Vial

Model Number	SIR-10200
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction

• Brand Name: SIROS D-Vial Prep Set
• Common Device Name: Shield, Vial
• Manufacturer (Section D): Sirtex Medical, Inc.; 300 unicorn park drive; fl. 2; woburn MA 01801
• Manufacturer Contact: melissa sanchez ; 300 unicorn park drive; fl. 2; woburn, MA 01801
• MDR Report Key: 50304824
• Report Number: 9710358-2026-00023
• Device Sequence Number: 10135894
• Product Code: IWW
• UDI-Device Identifier: 00850014612016
• UDI-Public: 00850014612016
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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
• Device Model Number: SIR-10200
• Device Lot Number: 1161682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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