MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 26" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, 2 MICROCLAVE® CLEAR, CLAM; STOPCOCK, I.V. SET

Catalog Number	AM3014
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation; it has not been received.The investigation is pending.
Event or Problem Description
Event occurred regarding ext set with 3 port nanoclave manifold, where it was reported that the product broke off from patient's catheter while medications were running.Patient harm is unknown.
Additional Manufacturer Narrative
The dhr was reviewed and no nonconformities were found that would have led to the reported complaint.The complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

• Brand Name: 26" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, 2 MICROCLAVE® CLEAR, CLAM
• 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: 24569756
• Report Number: 9617594-2026-00252
• Device Sequence Number: 8366776
• Product Code: FMG
• UDI-Device Identifier: 00887709086227
• UDI-Public: (01)00887709086227(17)290501(10)14009008
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: AM3014
• Device Lot Number: 14009008
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CALCIUM CHLORIDE, MFR UNKNOWN; DILAUDID, MFR UNKNOWN; PRECEDEX, MFR UNKNOWN; VASOPRESSION. MFR UNKNOWN
• Patient Sex: Unknown