MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VA; STOPCOCK, I.V. SET

Catalog Number	AM3127
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A lot number was not provided.Without a lot number a device history lot review cannot be performed.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved a 11" (28 cm) appx 1.1ml, smallbore ext set w/3-port nanoclave¿ manifold, check valve, clave¿ clear, luer lock where it was reported the manifold leaked.The event date occurred over 19-apr-2025 and 20-apr-2025.Status was during use on the patient.There was patient involvement but no human harm.However, there was a delay in therapy reported.

• Brand Name: 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VA
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22057283
• Report Number: 9617594-2025-01065
• Device Sequence Number: 8478104
• Product Code: FMG
• UDI-Device Identifier: 00887709122949
• UDI-Public: 00887709122949
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/20/2025

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: AM3127
• 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: 04/22/2025
• Initial Report FDA Received Date: 05/20/2025
• 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 Sex: Unknown