MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.28 ML, PRESSURE INFUSION (350PSIG) SMALLBORE EXT SET W/NEUTRON; ADMINISTRATION SETS AND ACCESSORIES

Catalog Number	NC101
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H4 - device mfr date and d4 - lot # was unknown the device has been received for evaluation; however, investigation is not yet complete.
Event or Problem Description
The event involved a 7" (18cm) pressure infusion (350psig) smallbore ext set with neutron, purple clamp, rotating luer with item number.It was reported that they had recent issues with the extension set with neutron valves that they use with the picc lines.Picc nurses have told that 3 incidences have occurred in the last two weeks with three different patients.The extension sets are reported to have been leaking and the one in the reporter office has blood backed up into the extension set.The event occurred during tpn or intralipid therapy on patients.There was patient involvement with no patient harm.There was no delay in therapy, and the extension set was replaced aseptically with new nc-101 extension set.The devices were attached to 1.4 french picc lines which is contaminated with blood and intralipids are present in the device and visually lipids are present around the blue neutron valve device.

• Brand Name: 7" (18 CM) APPX 0.28 ML, PRESSURE INFUSION (350PSIG) SMALLBORE EXT SET W/NEUTRON
• Common Device Name: ADMINISTRATION SETS AND ACCESSORIES
• 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: 25692495
• Report Number: 9617594-2026-00754
• Device Sequence Number: 9720143
• Product Code: FPA
• UDI-Device Identifier: 00887709036246
• UDI-Public: (01)00887709036246
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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: NC101
• 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: 06/12/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 15 DA
• Patient Sex: Male