MAUDE Adverse Event Report: COOK INCORPORATED COOK; CATHETER, PERCUTANEOUS

Model Number	G04035
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Noted cvc cracked at hub, medications leaking.Line was in place for 6 days.Required replacement.

• Brand Name: COOK
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8416033
• Report Number: 8416033
• Device Sequence Number: 13913195
• Product Code: DQY
• UDI-Device Identifier: 00827002040359
• UDI-Public: (01)00827002040359
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/27/2019
• Report Date (Section F): 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: G04035
• Device Catalogue Number: C-UDLM-401J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 02/27/2019