MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4 GANG 4-WAY NANOCLAVE® STOPCOCK W/ROTATING LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	AC400
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An email was received regarding a 4 gang 4-way nanoclave® stopcock w/rotating luer, alleging 4-gang stopcocks cracked during patient use.The device failed at picu (pediatric intensive care unit) with the registered nurse at the bedside.The device was replaced.There was patient involvement and no harm.There was maintenance intravenous fluids (mivf) mivf running through the 4-gang and it was attached to a central line which poses a risk for infection.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.

• Brand Name: 4 GANG 4-WAY NANOCLAVE® STOPCOCK W/ROTATING LUER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; CS 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25106848
• Report Number: 9617594-2026-00433
• Device Sequence Number: 18829284
• Product Code: FPA
• UDI-Device Identifier: 00887709090347
• UDI-Public: (01)00887709090347(17)290201(10)13903419
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2026

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: AC400
• Device Lot Number: 13903419
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 05/14/2026; 06/24/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/08/2026; 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: MAINTENANCE INTRAVENOUS FLUIDS (MIVF), UNK MFR.
• Patient Sex: Unknown