MAUDE Adverse Event Report: CAREFUSION 2200, INC; THORACENTESIS TRAY

Model Number	TPK1001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Upon inserting tpk cath into patient's peritoneal space, the catheter began to leak ascites out of the back when the needle was removed.

• Brand Name: NA
• Common Device Name: THORACENTESIS TRAY
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 24399815
• Report Number: 24399815
• Device Sequence Number: 8300124
• Product Code: PXI
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/12/2026
• Report Date (Section F): 02/12/2026

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: 001639676
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Date Report Sent to FDA: 02/12/2026