MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NEUSITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	NC5011R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Two separate iv access started and iv fluids will not flow to gravity.

• Brand Name: NEUSITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings rd; dublin OH 43016
• MDR Report Key: 9882427
• Report Number: 9882427
• Device Sequence Number: 2794759
• Product Code: FPA
• UDI-Device Identifier: 15019517133202
• UDI-Public: (01)15019517133202
• 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): 02/26/2020
• Report Date (Section F): 02/26/2020

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: NC5011R
• Device Lot Number: 18130
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/26/2020