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	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 4 gang 4-way nanoclave® stopcock with rotating luer a registered nurse was assessing a patient and noticed the manifold was split in half.There was patient involvement, and no harm reported.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary when additional reportable information becomes available.
Additional Manufacturer Narrative
Received one (1) used.List #ac400, 4 gang 4-way nanoclave® stopcock w/rotating luer; lot #unknown.The sample was observed to be broken in half.The reported complaint of a broken set could be confirmed.The returned sample was observed to be broken in half.The break was observed to have smooth and fracture marks.The probable cause is from an unintentional bending force during use.A device history review (dhr) could not be conducted.The reported lot number is too short and not in ifactory.

• 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 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22135871
• Report Number: 9617594-2025-01145
• Device Sequence Number: 12601935
• Product Code: FPA
• UDI-Device Identifier: 00887709090347
• UDI-Public: 00887709090347
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K100434
• 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
• Report Date (Section B): 07/22/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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