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

Model Number	G08686
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The package is labeled as a cook 10f x30cm sheath.The scrubber noticed that the actual sheath is labeled as a 14f sheath.This did not touch the patient.The scrubber noticed it as he was setting up the table.No harm to patient.

• Brand Name: CHECK-FLO
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 21592650
• Report Number: 21592650
• Device Sequence Number: 20920173
• Product Code: DYB
• UDI-Device Identifier: 00827002086869
• UDI-Public: (01)00827002086869
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/07/2025
• Report Date (Section F): 03/07/2025

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
• Device Model Number: G08686
• Device Catalogue Number: RCFW-10.0-38-30-RB
• Device Lot Number: 16376248
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2025
• 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: 03/07/2025