MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 25 CM (10") EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	011-AM3090
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation, however, it has not yet been received.
Event or Problem Description
An event involved a 25 cm (10") ext set w/3-port nanoclave manifold, check valve, clamp, luer lock.It was reported that the right valve was in good condition, the middle valve was sunken, and the left valve was slightly sunken.The right valve was used for continuous infusion.The middle valve, which had a red cap, was found broken.During an mri on (b)(6) 2025, while administering a bolus medication, the middle valve was observed to have sunk in.The red cap was later added to indicate the route was out of order (not caused by the cap).On (b)(6) 2025, the patient returned to the ward; the red cap signified the valve was unusable.A bolus medication was then administered through the left valve, which had sunk deeper and leaked medication outward.There was patient involvement, but no harm/adverse event reported.
Additional Manufacturer Narrative
One used device was received for evaluation.A stick down was observed on two of the nanoclaves.The reported complaint of a leak could be confirmed.The returned sample was observed to have multiple nanoclaves with a seal stuck down.The nanoclaves were disassembled and found to have damaged spikes.The probable cause of the leak is from the use of an incompatible mating device.The dfu states: needlefree connectors are compatible with iso male luers having an internal diameter between 0.062 inches (1.58 mm) and 0.110 inches (2.8 mm).Lot history review was conducted and no nonconformities were identified that may have contributed to the reported complaint.B.

• Brand Name: 25 CM (10") EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK
• 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: 23613494
• Report Number: 9617594-2025-02201
• Device Sequence Number: 8977318
• Product Code: FMG
• UDI-Device Identifier: 00840619091729
• UDI-Public: (01)00840619091729(17)300101(10)14270507
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: 011-AM3090
• Device Lot Number: 14270507
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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: UNSPECIFIED MEDICATION.
• Patient Sex: Unknown