MAUDE Adverse Event Report: BAXTER INTERNATIONAL, INC. DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1C8043
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient's medication was prepared by pharmacy that required a 3-piece set be attached, it was then delivered to infusion pod.The nurse returned to the window with it to show that part of the line was broken and when she hung the bag there was saline leaking from the line.The set that was broken was 1c8043.Pharmacy took back the med and primed and attached a new three piece set.The nurse returned a second time and the same section on the 1c8043 set was again broken and leaking when she tried to infuse dose.Pharmacy primed and attached new 3 piece set in order for patient to receive dose.The third set did not fall apart.

• Brand Name: DUO-VENT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL, INC.; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 8270045
• Report Number: 8270045
• Device Sequence Number: 1448558
• Product Code: FPA
• UDI-Device Identifier: 00085412019994
• UDI-Public: (01)00085412019994
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 12/21/2018
• Report Date (Section F): 12/21/2018

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: No Information
• Device Model Number: 1C8043
• Device Catalogue Number: 1C8043
• Device Lot Number: (10)R18C02182
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2019
• 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: 12/21/2018