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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.

• 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: 50735790
• Report Number: 9617594-2026-01251
• Device Sequence Number: 21491007
• Product Code: FPA
• UDI-Device Identifier: 00840619065485
• UDI-Public: (01)00840619065485(17)310701(10)15131454
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 15131454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2026
• 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: Normal saline, unk mfr; Unspecified tubing,Unk,mfr
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 94 LB