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	Break (1069)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 10" ext set w/3-port nanoclave® manifold, check valve, clamp, luer lock.It was reported that the nurse in the room sees blood rising in the tubing of the central line.She realized that there was a broken port (completely torn off) on a three-port icu medical that was in non-stock.There was patient involvement.Blood pressure drops but patient was fine.No harm was reported.
Additional Manufacturer Narrative
The device is available for evaluation, it has not been received.The investigation is pending.

• 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: 24958601
• Report Number: 9617594-2026-00397
• Device Sequence Number: 20144047
• Product Code: FMG
• UDI-Device Identifier: 00887709080799
• UDI-Public: (01)00887709080799(17)300101(10)14270682
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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: 14270682
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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
• Patient Sex: Unknown