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	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending.
Event or Problem Description
The event occurred on an unspecified date in january of 2025 involving a neutron¿ which the customer reported that when the patient needed labs drawn at midnight per request of the md, while drawing the labs it noticed that the cap of the purple lumen started to fill with blood and while flushing some normal saline (ns) had mixed with the blood trapped inside the cap.When disconnected the lab draw set up and noticed that the inner portion of the cap was depressed in and did not engage back to the top leaving the cap "open" i had to reconnect the lab draw set up to keep the line closed from contamination.We then changed the cap and lines.We believe the tubing used for blood administration via syringe may have caused the blood to enter the inside of the cap due to over depression of the cap¿s silicone top.It is possible that the blood syringe tubing with the male luer ending/connector might be too long and doesn¿t have a ¿stopper¿ to prevent over inserting the male luer end into the neutron.The neutron cap with blood collected inside septum channel and septum channel stuck in open position after blood transfusions.This occurred multiple times during a 6-day period.The patient was a 2-year-old female.There was patient involvement and unknown adverse events.
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history report (dhr) was reviewed and no nonconformities were found that would have led 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: 21747673
• Report Number: 9617594-2025-00616
• Device Sequence Number: 21205223
• Product Code: FPA
• UDI-Device Identifier: 00840619065485
• UDI-Public: (01)00840619065485(17)291001(10)14179031
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 14179031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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: SALINE, MFR UNK.
• Patient Age: 24 MO
• Patient Sex: Female