MAUDE Adverse Event Report: ICU MEDICAL, INC. SMALL BORE STOPCOCKS; STOPCOCK I.V. SET

Catalog Number	MX5341L
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that the stopcock was detached from the central venous line while running high dose vasopressor.The event occurred while in use with patient.Per reporter, the patient's blood pressure dropped.

• Brand Name: SMALL BORE STOPCOCKS
• Common Device Name: STOPCOCK I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 24682050
• Report Number: 1526863-2026-00082
• Device Sequence Number: 9976980
• Product Code: FMG
• UDI-Device Identifier: 10351688506788
• UDI-Public: (01)10351688506788(17)280528(10)6124720
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNKNOWN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2026

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: Other
• Device Catalogue Number: MX5341L
• Device Lot Number: 6124720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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