MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. Neutron¿; Set, administration, intravascular

Catalog Number	NC100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.E1 - initial reporter phone and email is unknown.

• Brand Name: Neutron¿
• Common Device Name: Set, administration, intravascular
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. De R.L. De C.V.; avenida cuarzo no. 250; ensenada, b.cfa. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50886182
• Report Number: 9617594-2026-01337
• Device Sequence Number: 15909298
• Product Code: FPA
• UDI-Device Identifier: 00840619065485
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: JA
• PMA/510(K) Number: K100434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NC100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown