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

Model Number	NC5000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Report about smiths medical clear needleless connectors.Reports of syringes slipping off of these needleless connectors by registered nurses in intensive care unit.

• 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: 19350977
• Report Number: 19350977
• Device Sequence Number: 7109650
• Product Code: FPA
• UDI-Device Identifier: 15019517133189
• UDI-Public: (01)15019517133189
• 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): 02/22/2024
• Report Date (Section F): 02/22/2024

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: NC5000
• Device Lot Number: 60083188
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/22/2024