MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. BAXTER -NON-DEHP THREE LEAD CATHETER EXTENSION SET; FILTER, INFUSION LINE

Model Number	2N3342
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the infusion of tpn product in the nicu it was noticed the tubing was leaking on the third day.The leaking was not in the connective part of the tubing.The tubing was due to be changed that day.There was no injury to the patient.There was no other medical follow-up necessary.

• Brand Name: BAXTER -NON-DEHP THREE LEAD CATHETER EXTENSION SET
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 8183985
• Report Number: 8183985
• Device Sequence Number: 1406783
• Product Code: FPB
• UDI-Device Identifier: 00085412004778
• UDI-Public: (01)00085412004778
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2018
• Report Date (Section F): 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 2N3342
• Device Catalogue Number: 2N3342
• Device Lot Number: (10) DR 18106024
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2018
• 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: 12/14/2018