MAUDE Adverse Event Report: CODAN US CORPORATION CODAN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	A 3002-W
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Defective tubing noted with kink in the filter section.

• Brand Name: CODAN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CODAN US CORPORATION; 3511 west sunflower ave.; santa ana CA 92704
• MDR Report Key: 7624645
• Report Number: 7624645
• Device Sequence Number: 1818966
• Product Code: FPA
• UDI-Device Identifier: 00813153022085
• UDI-Public: (01)00813153022085(17)210301(10)72730
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2018
• Report Date (Section F): 06/05/2018

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: No Information
• Device Expiration Date: 03/01/2021
• Device Model Number: A 3002-W
• Device Lot Number: 72730
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/05/2018