MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 11" SMALLBORE EXT SET W/NANOCLAVE®, 6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLA; STOPCOCK, I.V. SET

Catalog Number	AM6127
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.
Event or Problem Description
It was reported via email that an 11" smallbore ext set w/nanoclave®, 6-port nanoclave® manifold, check valve, clamp, rotating luer generated a leak during patient use.The patient was reported to have desaturated at 0600 hours, requiring several increases of phenylephrine, fluid boluses, and additional sedations as needed.The registered nurse (rn) identified leaking at the manifold during a safety check and emergently ordered new drips at 0700 hours and re-cocktailed medications.New drips were started at 1000 hour and within an hour, medications were able to be weaned.There is no additional information available at this time.

• Brand Name: 11" SMALLBORE EXT SET W/NANOCLAVE®, 6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLA
• 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: 24678711
• Report Number: 9617594-2026-00300
• Device Sequence Number: 10042028
• Product Code: FMG
• UDI-Device Identifier: 00887709086357
• UDI-Public: 00887709086357
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AM6127
• Device Lot Number: UNKNOWN
• 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: 03/16/2026
• Initial Report FDA Received Date: 03/24/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown