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	01/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation; however, has not been received.
Event or Problem Description
An event involved a 12 in (30 cm) appx 1.6 ml, ext set w/3-gang nanoclave stopcock w/nanoclave, spin luer where it was reported that upon assessment, flush line attached to the distal port of the manifold was detached hanging on floor.No air in line noted, line discontinued from patient.Normal saline (ns) flush running onto floor.There was patient involvement, and no harm reported.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history review could not be completed due to the unknown lot number.

• 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: 24529570
• Report Number: 9617594-2026-00231
• Device Sequence Number: 9071175
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: AC315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: NORMAL SALINE. UNK MFR.
• Patient Sex: Unknown