MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. NEUTRON®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	011-NC100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation, however, it has not yet been received.D4: only di provided as lot number is unknown.D4 - lot # - plots: 5772846, 13551866, 13551877, 13576574, 13806642, 13806645, 13970845, 14035583, 14226618, 14309851, 14460568, 14512775, 5829209, 9354100, 13551877, 13576574, 13590280, 13855914, 13889374, 13970845, 14309851, 14426618, 14460568, and 14512775.
Event or Problem Description
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.
Additional Manufacturer Narrative
D9 - date returned to mfr: 2/23/2026.Two used devices were returned for investigation.The devices were visually inspected and there was no significant damage or anomalies were noted.During functional testing, no leaks were confirmed.The complaint of leaks cannot be confirmed or replicated.A device history record (dhr) review could not be performed as the lot number was 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24033087
• Report Number: 9617594-2026-00016
• Device Sequence Number: 9140273
• Product Code: FPA
• UDI-Device Identifier: 00840619054076
• UDI-Public: 00840619054076
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 011-NC100
• Device Lot Number: UNKNOWN
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALARIS PUMP, UNK MFR; UNSPECIFIED CHEMO DRUG, UNK MFR
• Patient Sex: Unknown