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

Model Number	NC5001R
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Iv disconnected during mechanical power injection.This has been ongoing since 2017.Reported 10 cases total.Submitted a report that involved 5 incidents last month.This report includes 7 more incidents.
Event or Problem Description
Iv disconnected during mechanical power injection.This has been ongoing since 2017.Reported >10 cases total.Submitted a report that involved >5 incidents last month.This report includes 7 more incidents.

• Brand Name: NEUSITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11722893
• Report Number: 11722893
• Device Sequence Number: 17055638
• 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,Followup
• Report Date (Section B): 04/01/2021
• Report Date (Section F): 04/01/2021

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: No Information
• Device Model Number: NC5001R
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 04/26/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/01/2021