Neusite NC5011RRecalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15019517133202), received between Mar 25, 2020 and Feb 10, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Improper Flow or Infusion” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Improper Flow or Infusion3
- Fluid/Blood Leak2
- No Flow2
- Contamination1
- Loose or Intermittent Connection1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2023Fluid/Blood Leak; Material Puncture/Hole
WHILE REGISTERED NURSE (RN) WAS STARTING IV , RN PUT SALINE LOCK IN PLACE, DREW BACK TO ENSURE BLOOD RETURN AND DUE TO A HOLE IN THE TUBING, BLOOD SPILLED OUT. RN REPORTED IDENTIFYING IMMEDIATELY AND SHE HAD NOT FLUSHED THE LINE YET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16351032 ↗MalfunctionApr 26, 2021Fluid/Blood Leak; Loose or Intermittent Connection
LOOSE LUER LOCK CONNECTIONS AT SITE WHERE SMITH MEDICAL 7" STANDARD BORE EXTENSION SET CONNECT TO PRIMARY IV TUBING. THE THREADING LOOSENS WHEN AND THE IV LEAKS AT THE CONNECTION SITE. REQUIRES FREQUENT CHECKING AND TIGHTENING.
Patient problems: Insufficient Information
MAUDE report 11723414 ↗MalfunctionMar 31, 2021Contamination; Improper Flow or Infusion
IV EXTENSION SETS HAVE BEEN STOCKED RECENTLY AND THEY MALFUNCTION FREQUENTLY. WHEN SETTING UP IV TUBING TO PRIME, THE EXTENSION SET DOES NOT FLOW FREELY UNLESS IT IS DISCONNECTED AND RECONNECTED MULTIPLE TIMES. PERSISTENT WITH THIS NEW PRODUCT. HAVING TO CONNECT AND RECONNECT THIS TUBE TO GET IT TO PRIME IS AN INFECTION CONTROL RISK, AS WELL AS A WASTE OF PRODUCT, BECAUSE AFTER 3-4 ATTEMPTS IT IS NOW CONTAMINATED AND MUST BE THROWN AWAY AND A NEW ONE IS OPENED, WASTING PRODUCT.
Patient problems: Insufficient Information
MAUDE report 11594784 ↗MalfunctionSep 17, 2020Improper Flow or Infusion
A COMPLAINT WAS RECEIVED, PART NUMBER NC5011R, WHERE IV ACCESS WAS STARTED AND IV FLUIDS WOULD NOT FLOW TO GRAVITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10550599 ↗MalfunctionSep 17, 2020Improper Flow or Infusion
A COMPLAINT WAS RECEIVED, PART NUMBER NC5011R, WHERE IV ACCESS WAS STARTED AND IV FLUIDS WOULD NOT FLOW TO GRAVITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10550442 ↗MalfunctionMar 26, 2020No Flow
TWO SEPARATE IV ACCESS STARTED AND IV FLUIDS WILL NOT FLOW TO GRAVITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9882427 ↗MalfunctionMar 25, 2020No Flow
SMITHS MEDICAL 7" STANDARD BORE EXTENSION SET WITH REMOVABLE NEUSITE CLEAR NEEDLELESS CONNECTOR MALFUNCTIONED. WHEN CONNECTING IV FLUIDS TO EXTENSION SET THE FLUIDS WOULD NOT FREE FLOW. ATTEMPTED TO FLUSH, EXTENSION SET FLUSHED WITH EASE HOWEVER FLUIDS WOULD NOT FLOW TO GRAVITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9877134 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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