IV Plus® N8066Recalls & reported problems
Nexus Medical, LLC · 6" Minibore Extension Set with Nexus Split Septum T-Site, Rotating Luer & Pinch Clamp · Class 2
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10892855000970), received between Mar 25, 2026 and Mar 25, 2026 — classified as 1 death.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Air Embolism1
- Brain Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 25, 2026Insufficient Device Problem Information
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.
Patient problems: Air Embolism; Brain Injury
MAUDE report 24691255 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.