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

Model Number	NC5011R
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
While registered nurse (rn) was starting iv , rn put saline lock in place, drew back to ensure blood return and due to a hole in the tubing, blood spilled out.Rn reported identifying immediately and she had not flushed the line yet.

• Brand Name: NEUSITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 16351032
• Report Number: 16351032
• Device Sequence Number: 6836648
• 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): 01/19/2023
• Report Date (Section F): 01/19/2023

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: 19238
• 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: 02/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2023
• 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: Female
• Date Report Sent to FDA: 01/19/2023