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

Model Number NC5011R

Device Problems Contamination (1120); Improper Flow or Infusion (2954)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2020

Event Type  malfunction  

Event Description

Iv extension sets have been stocked recently and they malfunction frequently.When setting up iv tubing to prime, the extension set does not flow freely unless it is disconnected and reconnected multiple times.Persistent with this new product.Having to connect and reconnect this tube to get it to prime is an infection control risk, as well as a waste of product, because after 3-4 attempts it is now contaminated and must be thrown away and a new one is opened, wasting product.

• Brand Name: NEUSITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11594784
• MDR Text Key: 243131876
• Report Number: 11594784
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517133202
• UDI-Public: (01)15019517133202
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NC5011R
• Device Lot Number: 19080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1