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	09/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a neutron where it was reported moisture was noted on blanket at stopcock site at position of neutron valve after intermittent central venous pressure (cvp) line was recently added.The valve was not removed when cvp was added.Back up of infusions at neutron valve as visible appearance of same "rippled" with smof.Sterile procedure to remove neutron valve from line prior to stopcock and replace with new neutron valve at t-junction of stopcock to infusions.Connections confirmed as tight.No patient harm.
Additional Manufacturer Narrative
The device is available for evaluation; however, has not yet been received.D4: only di provided as lot number is unknown.Additional reporter: (b)(6).
Additional Manufacturer Narrative
One used neutron valve was returned for evaluation.Visual inspection and functional testing was carried out.Upon visual inspection no damages or anomalies were observed.Upon functional testing the sample was tested, primed at gravity pressure with no issues.The sample was pressure leak tested at 45psi with no leaks observed.No moisture was observed in the set.The reported complaint of moisture could not be confirmed.The returned sample was tested and met product specifications.D9 - date returned to mfg.: 11/24/2025.

• 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: 23496116
• Report Number: 9617594-2025-02136
• Device Sequence Number: 15732140
• Product Code: FPA
• UDI-Device Identifier: 00840619065485
• UDI-Public: 00840619065485
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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: 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: 10/23/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/30/2025
• 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: SMOF, UNK MFR.
• Patient Sex: Unknown