MAUDE Adverse Event Report: COOK INCORPORATED CHECK-FLO; INTRODUCER, CATHETER

Model Number	G12831
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Hub separated from dilator upon removal of dilator.

• Brand Name: CHECK-FLO
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7062727
• Report Number: 7062727
• Device Sequence Number: 19301141
• Product Code: DYB
• UDI-Device Identifier: 00827002128316
• UDI-Public: (01)00827002128316
• 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): 11/27/2017
• Report Date (Section F): 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: G12831
• Device Catalogue Number: XVCFW-22.0-35-25
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2017
• 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: 11/27/2017