MAUDE Adverse Event Report: CANADIAN HOSPITAL SPECIALTIES LIMITED MISI-MEDICAL IMAGING SOLUTIONS INTERNATIONAL; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	400109
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ct scan injector syringe broke while initializing and made a popping sound.Not used on a patient.Sterile saline was in the syringe.Syringe was removed and checked area for broken parts.

• Brand Name: MISI-MEDICAL IMAGING SOLUTIONS INTERNATIONAL
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): CANADIAN HOSPITAL SPECIALTIES LIMITED; 5800 west state road 80; lot 219; labelle FL 33935
• MDR Report Key: 23973834
• Report Number: 23973834
• Device Sequence Number: 13437935
• Product Code: DXT
• UDI-Device Identifier: 00628725095141
• UDI-Public: (01)00628725095141
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2025
• Report Date (Section F): 12/09/2025

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: Other
• Device Model Number: 400109
• Device Catalogue Number: 400109
• Device Lot Number: 208676
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/09/2025