MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12 IN (30 CM) APPX 1.6 ML, EXT SET W/3-GANG NANOCLAVE¿ STOPCOCK W/NANOCLAVE¿, SP; STOPCOCK, I.V. SET

Catalog Number	AC315
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.Additional reporter: (b)(6).
Event or Problem Description
An email was received regarding a 12 in (30 cm) appx 1.6 ml, ext set w/3-gang nanoclave¿ stopcock w/nanoclave¿, spin luer that leaked during patient use.The report states that the manifold was leaking at the distal port.The connections were checked and were not loose.No cracks were observed on either the manifold or the intravenous (iv) tubing set.The blood was backflowing into the manifold and the central venous catheter (cvc) line.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
One used device and photos were returned for investigation.The device was visually inspected.Dried up fluid residuals were observed at the connection of the nanoclave to the stopcock manifold at the proximal port.Examination of the connection showed an incomplete insertion.There was no leakage when fluid was infused.The dried-up fluid residuals had sealed the leak.The reported complaint of leakage can be confirmed.The probable root cause is due to an incomplete insertion during manual assembly in ensenada.A device history review could not be completed due to the unknown lot number.

• Brand Name: 12 IN (30 CM) APPX 1.6 ML, EXT SET W/3-GANG NANOCLAVE¿ STOPCOCK W/NANOCLAVE¿, SP
• 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: 24324664
• Report Number: 9617594-2026-00124
• Device Sequence Number: 13263204
• Product Code: FMG
• UDI-Device Identifier: 00887709121379
• UDI-Public: 00887709121379
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: AC315
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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: SALINE. (BAXTER NACL 0.9%)
• Patient Sex: Unknown