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

Model Number	NC5001R
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
4 instances of neusite small bore disconnecting during power injection.

• 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: 11602007
• Report Number: 11602007
• Device Sequence Number: 14275714
• Product Code: FPA
• UDI-Device Identifier: 15019517133226
• UDI-Public: (01)15019517133226
• 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): 03/16/2021
• Report Date (Section F): 03/16/2021

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: Other
• Device Model Number: NC5001R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2021
• 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: 03/16/2021