ICU Medical 011-NC100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840619054076), received between Oct 11, 2019 and Mar 2, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A NEUTRON WHERE THE CUSTOMER REPORTED THAT BLOOD LEAKAGE WAS OBSERVED FROM ONE LUMEN LIKELY DUE TO THE ABSENCE OR INEFFECTIVENESS OF THE BLOOD REFLUX SYSTEM. THERE WAS PATIENT INVOLVEMENT; MEDICAL INTERVENTION WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483940 ↗
• MalfunctionJan 12, 2026Fluid/Blood Leak

  AN INCIDENT INVOLVING A NEUTRON® REPORTER STATED LEAKING NEUTRON IDENTIFIED DURING ADMINISTRATION OF CHEMOTHERAPY, CYTOTOXIC SPILL OCCURRED, 3RD IDENTIFIED EVENT WITHIN 1 WEEK. ADDITIONAL EVENT OCCURRED ON (B)(6) 22, NO HARM OCCURRED AS FAULT IDENTIFIED BEFORE ADMINISTRATION. ALARIS GIVING SET ATTACHED TO NEUTRON NEEDLESS ACCESS VALVE ¿ LEAKING NOT OBSERVED AT THREAD OR SEPTUM. THERE WAS PATIENT INVOLVEMENT AND DELAY IN THE THERAPY BUT NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24033087 ↗
• MalfunctionJun 13, 2025Break; Break

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY 2025 AND INVOLVED A NEUTRON®. IT WAS STATED THAT THE CANCER SERVICES AT GOSFORD HAVE REPORTED A QUALITY ISSUE WITH THE NEUTRON NEEDLESS CONNECTOR. THE VALVE HAS SNAPPED OFF INSIDE THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LUMEN, AND THE PICC NEEDED TO BE REPLACED. THE ISSUE WAS NOTED DURING USE ON PATIENT. THERE WAS PATIENT INVOLVEMENT AND DELAY IN THERAPY, BUT NO ONE WAS HARMED IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203429 ↗
• MalfunctionJan 21, 2025Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  THE EVENT INVOLVED A NEUTRON® WHERE IT WAS REPORTED THERE WAS A LOSS OF MEDICINAL PRODUCT FROM THE SMART CONNECTED TO THE JUGULAR CATHETER (PRIMICATH). ONCE THE DEVICE HAS BEEN REMOVED FROM THE CHILD: TESTING THE SMART WITHOUT APPLYING UPSTREAM PRESSURE: NO ANOMALIES WERE OBSERVED. TESTING THE SMART WHILE APPLYING UPSTREAM PRESSURE: THE PRODUCT BACKFLOW AND LEAK. THE CORRECTIVE ACTION WAS TO REPLACE THE SMART DEVICE. NO CLINICAL CONSEQUENCES HAVE BEEN NOTED. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT IS WHILE CONNECTED TO THE JUGULAR CATHETER. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT/HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200957 ↗
• MalfunctionApr 30, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A NEUTRON® AT THE END OF THE INFUSION OF THE LAVAGE OF THE CHEMOTHERAPY, A WET PART OF THE BANDAGE WAS NOTED AND SOME DROPS WERE FALLING FROM THE NEUTRON, LEAKING LATERALLY. A SMALL SIDE CRACK WAS NOTED ON THE DEVICE. THE DEVICE WAS IN USE FOR 48 HOURS PRIOR TO THE EVENT. THERE WAS NO ADVERSE EVENT, NO DELAY IN CRITICAL THERAPY, NO BLOOD LOSS AND THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10013703 ↗
• MalfunctionOct 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, THE NURSE NOTICED BLOOD LEAKING/DRIPPING OUT OF PICC AT A FAST RATE. IT WAS REPORTED THAT THE PATIENT HAD JUST HAD IV MEDICATIONS GIVEN THROUGH THE LUMEN A FEW MINUTES EARLIER. THE NURSING STAFF CLAMPED THE LUMEN AND CHANGED THE NEUTRON, WHICH WAS REPORTED TO HAVE STOPPED THE FLOW OF BLOOD. UPON FURTHER INVESTIGATION, BY STAFF, IT WAS ALLEGED THAT THE NEUTRON WAS DAMAGED WITH THE WHITE/CLEAR 'STOPPER' AT THE TIP HAVING FALLEN OUT. THERE WAS NO HARM TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 9182437 ↗