MAUDE Adverse Event Report: NEXUS MEDICAL, LLC NEXUS TKO®; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	NX4650
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse was called to the bedside by the patient family as they noticed that there was blood inside the nexus iv cap.

• Brand Name: NEXUS TKO®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): NEXUS MEDICAL, LLC; 11315 strang line road; lenexa KS 66215
• MDR Report Key: 22122296
• Report Number: 22122296
• Device Sequence Number: 4149147
• Product Code: FPA
• UDI-Device Identifier: 10892855000505
• UDI-Public: (01)10892855000505
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2025
• Report Date (Section F): 05/28/2025

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
• Device Model Number: NX4650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 17 MO
• Patient Sex: Male
• Patient Weight: 11 KG
• Date Report Sent to FDA: 05/28/2025