MAUDE Adverse Event Report: NEXUS MEDICAL, LLC IV PLUS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N8066
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Air Embolism (1697); Brain Injury (2219)
Date of Event	02/09/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
No device was returned for evaluation.The reported lot number is under review as part of the ongoing investigation.At the time of this report, no device-specific malfunction has been identified.The manufacturer is continuing to monitor for additional information related to this event and will update the report as appropriate.
Event or Problem Description
Manufacturer received a report from a user facility (b)(4) describing a neonatal patient with an arterial line in place.The patient developed mottling of the left arm, chest, and back, along with decreased perfusion to the hand.The arterial line was removed.Ultrasound imaging of the left upper extremity and head identified a large amount of air emboli.The patient experienced worsening lactic acidosis following medication administration and intubation.Subsequent imaging (head ultrasound, ct, and mri) indicated extensive brain injury.The patient subsequently expired.Therapies that may have contributed to the event were not reported.The device was not returned to the manufacturer for evaluation.The manufacturer has requested additional information from the user facility and received a response; however, sufficient detail was not provided to further assess the event.Based on the information available, the relationship of the device to the reported event cannot be determined at this time.The manufacturer has initiated an investigation.A follow-up report will be submitted if additional relevant information becomes available.
Additional Manufacturer Narrative
Based on information received from the reporting facility, the nexus device was connected within the line but no visible cracking, separation, or leakage was reported.Key details regarding device access history, syringe flushing, and specific interactions with the septum were unknown.A complaint history review identified no similar complaints associated with this device model or equivalent t site configurations.Review of the device history record for the reported lot confirmed that all manufacturing, inspection, and release requirements were met with no identified nonconformances.In addition, component inspection and qualification records met applicable acceptance criteria.Because no physical sample was returned, the investigation included review of provided images and in house functional testing of retained samples.Retained devices met all applicable performance requirements.No failures or abnormalities were observed during testing.Based on the available information, review of records, visual assessment, and in house testing, no evidence of device malfunction or performance outside specifications was identified.The nexus medical extension set was determined not to be a contributing factor to the reported event.

• Brand Name: IV PLUS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): NEXUS MEDICAL, LLC; 11315 strang line road; lenexa KS 66215
• Manufacturer Contact: josh hughey ; 11315 strang line road; lenexa, KS 66215 ; 9134512234
• MDR Report Key: 24691255
• Report Number: 3004194523-2026-00001
• Device Sequence Number: 9653576
• Product Code: FPA
• UDI-Device Identifier: 10892855000970
• UDI-Public: 10892855000970
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K092930
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: N8066
• Device Lot Number: 23322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Death
• Patient Sex: Female