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; SET, ADMINISTRATION, INTRAVASCULAR

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
Event or Problem Description
An event involved a 7" (18 cm) pressure infusion (350psig) smallbore ext set with neutron, purple clamp, rotating luer it was reported that had recent issues with the extension set with neutron valves that they use with the picc lines.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.
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.No product samples, pictures, or videos were received for investigation.Without the return of the sample used, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The dhr lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.Plot d4 - lot # (h4 - device mfr date and d4 - expiration date) d4 - primary udi number: 14065085 - 06/29/2024 and 06/01/2029 - (b)(4).

• Brand Name: 7" (18 CM) APPX 0.28 ML, PRESSURE INFUSION (350PSIG) SMALLBORE EXT SET W/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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25719258
• Report Number: 9617594-2026-00774
• Device Sequence Number: 10644719
• 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: K100576
• 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): 07/06/2026

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: NC101
• Device Lot Number: PLOT
• 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: 06/12/2026
• Initial Report FDA Received Date: 07/06/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTRALIPID 1.4 FRENCH, UNF, MFR.
• Patient Sex: Unknown