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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. NEUSITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameNEUSITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key11594784
MDR Text Key243131876
Report Number11594784
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received03/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNC5011R
Device Lot Number19080
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/16/2021
Event Location Hospital
Date Report to Manufacturer03/31/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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