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

Catalog Number	AM3090
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used and one new device were received for evaluation.A nanoclave housing was observed to be separated from the manifold on the used sample.No visual damages or anomalies were observed on the new sample.The reported complaint of a broken port could be confirmed.The returned sample was observed to have a broken port upon arrival.The probable cause of the broken port is from an unintentional bending force during use.Lot history review was conducted, and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved a 10" ext set w/3-port nanoclave® manifold, check valve, clamp, luer lock where the customer reported that the port broke off while in use on a patient.Harm was not reported as a consequence of this event.

• Brand Name: 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: 24180865
• Report Number: 9617594-2026-00032
• Device Sequence Number: 9557431
• Product Code: FMG
• UDI-Device Identifier: 00887709080799
• UDI-Public: (01)00887709080799(17)290901(10)14145081
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2026

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: AM3090
• Device Lot Number: 14145081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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