MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CONTINUE-FLO SOLUTION SET PRIMARY IV TUBING ; SET, ADMINISTRAION, INTRAVASCULAR

Model Number	2C8546
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Defect noted on iv tubing set.Fda safety report id# (b)(4).

• Brand Name: CONTINUE-FLO SOLUTION SET PRIMARY IV TUBING
• Common Device Name: SET, ADMINISTRAION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 9317602
• Report Number: MW5091055
• Device Sequence Number: 10846761
• Product Code: FPA
• UDI-Device Identifier: 00085412048987
• UDI-Public: (01)00085412048987
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

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: 2C8546
• Device Catalogue Number: 2C8546
• Device Lot Number: (10)R19H11017
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1