MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12 IN (30 CM) APPX 1.6 ML, EXT SET W/3-GANG NANOCLAVE¿ STOPCOCK W/NANOCLAVE¿, SP; STOPCOCK, I.V. SET

Catalog Number	AC315
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred regarding 12 in (30 cm) appx 1.6 ml, ext set where it was stated in the report that the product failed during use.The nanoclave proximal to the patient broke in such a way that the outer plastic piece became completely disconnected from the inner lumen.There were patient involvement and no patient harm reported.
Additional Manufacturer Narrative
The device has been received for evaluation.The investigation is pending completion.
Additional Manufacturer Narrative
One used sample along with two photos were received.Visual inspection was carried out.The nano clave housing was missing from the stopcock.The housing was broken from the manifold, and the internal spike was bent.Examination of the break showed one side higher than the other and the weld still intact.A device history lot review could not be conducted because no lot number(s) was we/were identified.The reported complaint can be confirmed.The probable cause is due to an unintentional bending force during use.Updated information in h3.

• Brand Name: 12 IN (30 CM) APPX 1.6 ML, EXT SET W/3-GANG NANOCLAVE¿ STOPCOCK W/NANOCLAVE¿, SP
• 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: 23649751
• Report Number: 9617594-2025-02223
• Device Sequence Number: 4903512
• Product Code: FMG
• UDI-Device Identifier: 00887709121379
• UDI-Public: 00887709121379
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: AC315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/21/2025
• 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