MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" (25 CM) APPX 1.0 ML, SMALLBORE EXT SET W/6-PORT NANOCLAVE¿ MANIFOLD, CHECK V; STOPCOCK, I.V. SET

Catalog Number	AM6154
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as lot number is unknown.
Event or Problem Description
The event occurred on various unspecified dates in april and may 2025 and involved a 10" (25 cm) appx 1.0 ml, smallbore ext set w/6-port nanoclave¿ manifold, check valve (orange, glow, blue, purple, yellow, green rings), nanoclave¿, luer lock.It was reported there was leaking where the cap on the end connects and various leaking from port connection sites.There was patient involvement and no adverse event.This report captures 5 occurrences.
Additional Manufacturer Narrative
Received five used list #am6154, 10" (25 cm) appx 1.0 ml, smallbore ext set w/6-port nanoclave¿ manifold, check valve (orange, glow, blue, purple, yellow, green rings), nanoclave¿ and one used.List #unknown, extension set w/ filter for inspection.A stickdown condition was observed on one of the samples.The male luer was broken and stuck down in the microclave.No other damages or anomalies were observed on any of the samples.The five samples were observed to have a leak on the connection of the tubing and the manifold.The reported complaint of a leak was confirmed on the five sample devices.The probable cause is from an incomplete insertion during the assembly process of manufacturing.There was also a stickdown from a broken male luer in the microclave, the probable cause is from an unintentional bending force.The device history record could not be conducted because no lot number was identified.

• Brand Name: 10" (25 CM) APPX 1.0 ML, SMALLBORE EXT SET W/6-PORT NANOCLAVE¿ MANIFOLD, CHECK V
• 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: 22357218
• Report Number: 9617594-2025-01386
• Device Sequence Number: 15466947
• Product Code: FMG
• UDI-Device Identifier: 00887709126886
• UDI-Public: 00887709126886
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: AM6154
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/18/2025
• 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
• Patient Sex: Unknown