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

Model Number	G05463
Health Effect - Clinical Codes	Pneumothorax (2012); Low Oxygen Saturation (2477)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Icu patient's oxygen saturation dropped.Patient had a pneumothorax and needed chest tube.The md emergently attempted to place chest tube.When using the thal quick chest tube tray, the obturator and needle stuck together.The health care providers needed to open another kit to complete the chest tube placement.

• Brand Name: COOK
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11222258
• Report Number: 11222258
• Device Sequence Number: 3842295
• Product Code: GBX
• UDI-Device Identifier: 00827002054639
• UDI-Public: (01)00827002054639
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/19/2021
• Report Date (Section F): 01/19/2021

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: Health Professional
• Device Model Number: G05463
• Device Catalogue Number: C-TQTSY-2000
• Device Lot Number: 13215884
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 95
• Date Report Sent to FDA: 01/19/2021