MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH; STOPCOCK, I.V. SET

Catalog Number	A1141
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: received one (1) used a1141 smallbore trifuse ext set for inspection.Tpn fluid residuals were observed inside of the housing of the nanoclave.The set was leak tested per product specifications.There was no leakage, and the internal leakage could not be replicated.The nanoclave was diassembled.No defects or anomalies were found that would lead to the internal leakage observed.The reported complaint could not be replicated but can be confirmed based on the fluid residuals in the housing of the nanoclave.The probable cause of the internal leakage is unknown.No mating devices were returned for inspection.A device history record lot review could not be conducted because no lot number(s) was/were identified.
Event or Problem Description
Event occurred regarding 9.5-inch smallbore trifuse ext set w/3 microclave clear, nanoclave (red ring), 3 check valves, 4 clamps (yellow, light green, 2 white), luer lock where it was stated that "a large wet spot was found under the quad set.The neonatal nurse practitioner (nnp) ordered to restring total parenteral nutrition (tpn) and check a glucose level.When disconnected and flushed through the red port was found to be leaking." there was patient involvement but no patient harm.

• Brand Name: 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH
• Common Device Name: STOPCOCK, I.V. SET
• 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: 23455157
• Report Number: 9617594-2025-02121
• Device Sequence Number: 15705407
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: 00887709069343
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2025

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: A1141
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/03/2025
• 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: TOTAL PARENTERAL NUTRITION, MFR UNKNOWN.
• Patient Sex: Unknown