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

Model Number	TPK1001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During a paracentesis, the tpk catheter started to leak where it should be leakproof.When pulling out the stylet, the peritoneal fluid leaks everywhere.Manufacturer response for needle, catheter thora-para catheter (per site reporter).They are aware and will be doing an analysis of the returned product.

• Brand Name: THORA-PARA 8 FR CATHETER DRAINAGE KIT
• Common Device Name: NEEDLE, CATHETER
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 9465649
• Report Number: 9465649
• Device Sequence Number: 16603019
• Product Code: GCB
• UDI-Device Identifier: 10885403076121
• UDI-Public: (01)10885403076121
• 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): 12/06/2019
• Report Date (Section F): 12/06/2019

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: 0001318899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2019
• 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: 12/06/2019