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

Model Number	TPT1000SP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Noticed that there was debris in one of the test tubes in the kit.

• Brand Name: SAFE-T
• Common Device Name: THORACENTESIS TRAY
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 20587064
• Report Number: 20587064
• Device Sequence Number: 17781599
• Product Code: PXI
• UDI-Device Identifier: 10885403108433
• UDI-Public: (01)10885403108433
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/20/2024
• Report Date (Section F): 08/20/2024

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
• Device Model Number: TPT1000SP
• Device Catalogue Number: TPT1000SP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2024
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/20/2024