MAUDE Adverse Event Report: CANADIAN HOSPITAL SPECIALTIES LTD. MEDICAL IMAGING SOLUTIONS INTL.; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	400109
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Misi ct power injector syringe found to be broken upon opening of package.The "male connection nipple" where the tubing attaches was broken off from the tip of the syringe.

• Brand Name: MEDICAL IMAGING SOLUTIONS INTL.
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): CANADIAN HOSPITAL SPECIALTIES LTD.; 200 kelly drive suite a.; peachtree city GA 30269
• MDR Report Key: 19728699
• Report Number: 19728699
• Device Sequence Number: 18179588
• Product Code: DXT
• UDI-Device Identifier: 00850014500344
• UDI-Public: (01)00850014500344
• 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): 04/22/2024
• Report Date (Section F): 04/22/2024

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: 400109
• Device Catalogue Number: 400109
• Device Lot Number: 2310242
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2024
• 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: 04/22/2024