MAUDE Adverse Event Report: ICU MEDICAL ASD, INC. MEDEX 3-WAY STOPCOCK; STOPCOCK I.V. SET

Catalog Number	MX5311L
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2026
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 a stopcock control valve disconnected from its housing while in use.Per reporter, the device had been in use for three days and was fully disconnected from the line it controlled, making it impossible to regulate flow from the associated femoral arterial line.Reporter stated the event occurred while attempting to draw blood from the arterial line, as the white stopcock valve became disconnected during turning.There was no patient harm, and no medical intervention was required.The patient's arterial line was removed.
Additional Manufacturer Narrative
No devices were returned and the investigation could not confirm the reported issue.No corrective actions are currently planned.A 2-year complaint history found no complaints for separation issues.A device history review (dhr) was performed for lot numbers provided and no ncmr¿s were found for reported issue.No maintenance work orders were completed of lot.

• Brand Name: MEDEX 3-WAY STOPCOCK
• Common Device Name: STOPCOCK I.V. SET
• Manufacturer (Section D): ICU MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 24317918
• Report Number: 1526863-2026-00017
• Device Sequence Number: 20227046
• Product Code: FMG
• UDI-Device Identifier: 10351688506795
• UDI-Public: (01)10351688506795(17)271217(10)6084136
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: MX5311L
• Device Lot Number: 6084136
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Unknown
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American