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 Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
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.
Additional Manufacturer Narrative
One used neutron® connectors were returned for evaluation.The returned devices were visually inspected, and residual total parenteral nutrition (tpn) and lipid solution were observed.No additional external damage or anomalies were noted.Functional testing was performed in accordance with established procedures, and leakage was confirmed in one of the returned devices.The devices were disassembled for further evaluation.A bent spike and a completely torn seal extending from top to bottom were observed.The probable root cause was determined to be used with an incompatible mating device, resulting in damage to the seal.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 25243993
• Report Number: 9617594-2026-00487
• Device Sequence Number: 10548486
• Product Code: FPA
• UDI-Device Identifier: 00840619065485
• UDI-Public: (01)00840619065485(17)300901(10)14595360
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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
• Device Lot Number: 14595360
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• 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: LIPIDS, MFR UNKNOWN.; TPN, UNKNOWN MFR.
• Patient Sex: Unknown