Neusite NC5011BRecalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517133196), received between Sep 17, 2020 and Mar 29, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).
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.
Most reported problems
Device problems
- Physical Resistance/Sticking2
- Positioning Failure2
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2021Connection Problem; Connection Problem
A COMPLAINT WAS RECEIVED, PART NUMBER NC5011B, 7" (18 CM) STANDARD BORE EXTENSION SET WITH BONDED NEUSITE¿ CLEAR NEEDLELESS CONNECTOR (APV 0.65 ML) PRESSURE RATED TO 325 PSI, LOT NUMBER 19286. THE REMOVABLE COLLAR WAS DIFFICULT TO PULL DOWN AND GETS STUCK.
Patient problems: Insufficient Information
MAUDE report 11586525 ↗MalfunctionSep 17, 2020Positioning Failure; Physical Resistance/Sticking
A COMPLAINT WAS RECEIVED, PART NUMBER NC5011B- LOT # 19292, DUE TO THE SLIDING COLLAR NOT BEING ABLE TO MOVE. WHEN IT DOES MOVE IT IS STICKY AS IF THERE IS DRIED GLUE OBSTRUCTING THE MOVEMENT OF THE SPINNING COLLAR. THE CONNECTION TO THE CATHETER HUB COULD NOT BE MADE SECURELY ENOUGH TO WITHSTAND A CT PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10550748 ↗MalfunctionSep 17, 2020Positioning Failure; Physical Resistance/Sticking
A COMPLAINT WAS RECEIVED, PART NUMBER NC5011B- LOT # 19292, DUE TO THE SLIDING COLLAR NOT BEING ABLE TO MOVE. WHEN IT DOES MOVE IT IS STICKY AS IF THERE IS DRIED GLUE OBSTRUCTING THE MOVEMENT OF THE SPINNING COLLAR. THE CONNECTION TO THE CATHETER HUB COULD NOT BE MADE SECURELY ENOUGH TO WITHSTAND A CT PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10550092 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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