ICU Medical NC100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840619065485), received between Apr 6, 2023 and Sep 24, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fluid/Blood Leak

  The event involved a Neutron. The reporter stated Neutron was found broken and a leakage had occurred. Anti-cancer drugs were not used in this case. The event occurred during infusion and was not Detected Prior to Direct Patient Use. There was no Serious Injury/death, no Blood loss, no Unprotected Chemo Exposure, no Delay in Critical Therapy, no Adverse Operator Consequences, no Med/Surg intervention required, the device was changed out/replaced with no further problems encountered, Involved device is available to be tested, the product was not disposed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886182 ↗
• MalfunctionSep 11, 2026No Flow

  A reported incident involved a Neutron Needle free Connector attached to a patient¿s midline. It was reported that during a routine flush normal saline before a laboratory blood draw, the line could not be flushed, and blood could not be aspirated. When the connector was removed, blood immediately backed into the tubing. Upon inspection the rubber center of the clave collapsed into the clave and will not allow forward or backward movement. Clave changed. The event occurred during patient use; however, no patient harm or injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735790 ↗
• MalfunctionAug 4, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50126010 ↗
• MalfunctionJul 6, 2026Crack; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A NEUTRON WITH LHERE IT WAS REPORTED THAT THE NC100 CLAVE HAS 2 NEUTRONS, ONE NEUTRON REPORTED TO BE LEAKING IN THE CENTER OF CLAVE WHEN FLUSHED, WITH FLUID COLLECTING AROUND THE HOLLOW SPACE INSIDE THE CAP BUT OUTSIDE OF THE CENTER BLUE PORTION, NO VISIBLE CRACKS ARE SEEN. AND THE OTHER NEUTRON LEAKING TPN AND LIPIDS WITH A LARGE VISIBLE CRACK IN THE INTERNAL CENTER BLUE PORTION ALLOWING FLUIDS TO COLLECT IN THE HOLLOW SPACE INSIDE THE CAP. THERE WAS PATIENT INVOLVEMENT BUT UNKNOWN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25725823 ↗
• MalfunctionJun 16, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A NEUTRON, AND IT WAS REPORTED THAT THE TOTAL PARENTERAL NUTRITION AND LIPIDS LEAKED INTO THE EMPTY SPACE BETWEEN THE OUTSIDE OF THE NEUTRON AND THE INNER CHAMBER. THERE WAS PATIENT INVOLVEMENT, AND PATIENT HARM IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25516874 ↗
• MalfunctionMay 21, 2026Crack; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A NEUTRON WITH LHERE IT WAS REPORTED THAT THE NC100 CLAVE HAS 2 NEUTRONS, ONE NEUTRON REPORTED TO BE LEAKING IN THE CENTER OF CLAVE WHEN FLUSHED, WITH FLUID COLLECTING AROUND THE HOLLOW SPACE INSIDE THE CAP BUT OUTSIDE OF THE CENTER BLUE PORTION, NO VISIBLE CRACKS ARE SEEN. AND THE OTHER NEUTRON LEAKING TPN AND LIPIDS WITH A LARGE VISIBLE CRACK IN THE INTERNAL CENTER BLUE PORTION ALLOWING FLUIDS TO COLLECT IN THE HOLLOW SPACE INSIDE THE CAP. THERE WAS PATIENT INVOLVEMENT BUT UNKNOWN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243993 ↗
• MalfunctionNov 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A NEUTRON WHERE IT WAS REPORTED MOISTURE WAS NOTED ON BLANKET AT STOPCOCK SITE AT POSITION OF NEUTRON VALVE AFTER INTERMITTENT CENTRAL VENOUS PRESSURE (CVP) LINE WAS RECENTLY ADDED. THE VALVE WAS NOT REMOVED WHEN CVP WAS ADDED. BACK UP OF INFUSIONS AT NEUTRON VALVE AS VISIBLE APPEARANCE OF SAME "RIPPLED" WITH SMOF. STERILE PROCEDURE TO REMOVE NEUTRON VALVE FROM LINE PRIOR TO STOPCOCK AND REPLACE WITH NEW NEUTRON VALVE AT T-JUNCTION OF STOPCOCK TO INFUSIONS. CONNECTIONS CONFIRMED AS TIGHT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496116 ↗
• MalfunctionApr 1, 2025No Flow; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN JANUARY OF 2025 INVOLVING A NEUTRON¿ WHICH THE CUSTOMER REPORTED THAT WHEN THE PATIENT NEEDED LABS DRAWN AT MIDNIGHT PER REQUEST OF THE MD, WHILE DRAWING THE LABS IT NOTICED THAT THE CAP OF THE PURPLE LUMEN STARTED TO FILL WITH BLOOD AND WHILE FLUSHING SOME NORMAL SALINE (NS) HAD MIXED WITH THE BLOOD TRAPPED INSIDE THE CAP. WHEN DISCONNECTED THE LAB DRAW SET UP AND NOTICED THAT THE INNER PORTION OF THE CAP WAS DEPRESSED IN AND DID NOT ENGAGE BACK TO THE TOP LEAVING THE CAP "OPEN" I HAD TO RECONNECT THE LAB DRAW SET UP TO KEEP THE LINE CLOSED FROM CONTAMINATION. WE THEN CHANGED THE CAP AND LINES. WE BELIEVE THE TUBING USED FOR BLOOD ADMINISTRATION VIA SYRINGE MAY HAVE CAUSED THE BLOOD TO ENTER THE INSIDE OF THE CAP DUE TO OVER DEPRESSION OF THE CAP¿S SILICONE TOP. IT IS POSSIBLE THAT THE BLOOD SYRINGE TUBING WITH THE MALE LUER ENDING/CONNECTOR MIGHT BE TOO LONG AND DOESN¿T HAVE A ¿STOPPER¿ TO PREVENT OVER INSERTING THE MALE LUER END INTO THE NEUTRON. THE NEUTRON CAP WITH BLOOD COLLECTED INSIDE SEPTUM CHANNEL AND SEPTUM CHANNEL STUCK IN OPEN POSITION AFTER BLOOD TRANSFUSIONS. THIS OCCURRED MULTIPLE TIMES DURING A 6-DAY PERIOD. THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21747673 ↗
• MalfunctionApr 1, 2025No Flow; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) OF 2025 INVOLVING A NEUTRON¿ WHERE THE CUSTOMER STATED THAT, ¿S: PATIENT RECEIVED 3 CAP CHANGES DURING A 6-DAY PERIOD. 2 CAP CHANGES WERE PREMATURELY DONE DUE TO POSSIBLE CAP MALFUNCTION. B: PATIENT WAS RECEIVED BLOOD TRANSFUSION ON [REDACTED], A 2ND SYRINGE (ALIQUOT) WAS ADMINISTERED AT 1740 IN THE PURPLE LUMEN AND CAME DOWN AT 2048. BEFORE DISCONNECTING THE BLOOD, THE NURSE (RN) NOTICED SOME BLOOD ON THE THREADS OF THE CAP. RN WIPED THE OUTSIDE OF THE CAP WITH CHG SWAB, BUT UPON CLOSER INSPECTION THE INSIDE OF THE CAP HAD A VERY SMALL AMOUNT OF BLOOD. WHEN FLUSHING THE LINE, THE FLUIDS FLUSHING DID NOT ENTER THE EMPTY SPACE OF THE CAP, THE BLOOD TUBING HAD BLOOD ON THE THREADS ON THE END. THE RN BELIEVES THAT WHEN BLOOD WAS OVER PRIMED WHERE A SMALL AMOUNT ON THE END SOMEHOW ENTERED THE CAP WHEN IT WAS BEING CONNECTED. THE RN KEPT THE CAP ON PATIENT TO DO A CHANGE WITH 4AM LAB DRAWS TO MINIMIZE ENTERING PATIENT LINE MULTIPLE TIMES. RN CONTINUOUSLY CHECKED ON THE CAP TO ENSURE NO CHANGES OCCURRED. ON [REDACTED] AT 0352 CAP ON THE PURPLE LUMEN WAS CHANGED (WAS UNABLE TO CHANGE CAP ON WHITE LUMEN BECAUSE IT WAS INFUSING TPN/LIPIDS/

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21742463 ↗
• MalfunctionApr 6, 2023Air/Gas in Device; Air/Gas in Device

  THE EVENT INVOLVED A NEUTRON¿ THAT WAS REPORTED TO CONTAIN AIR IN LINE FROM THE CLAMP TO THE HUB ON THE BLUE LUMEN. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO APPARENT HARM THAT REACHED THE PATIENT/PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690348 ↗