MAUDE Adverse Event Report: CAREFUSION 2200, INC THORA-PARA 8 FR CATHETER DRAINAGE KIT; THORACENTESIS TRAY

Model Number	TPK1001
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Incident description: tpk was placed during a paracentesis.The tpk malfunctioned and would not drain.The tpk had to be removed and a new catheter had to be placed.There were no complications.

• Brand Name: THORA-PARA 8 FR CATHETER DRAINAGE KIT
• Common Device Name: THORACENTESIS TRAY
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10634286
• Report Number: 10634286
• Device Sequence Number: 16778135
• Product Code: PXI
• UDI-Device Identifier: 10885403076121
• UDI-Public: (01)10885403076121(10)0001360938(17)250430
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/30/2020
• Report Date (Section F): 09/30/2020

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: TPK1001
• Device Catalogue Number: TPK1001
• Device Lot Number: 0001360938
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2020
• 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: 09/30/2020