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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two stopcocks connected in series became disconnected during patient turn, resulting in an interruption of vasopressor infusion (norepinephrine).Following the disconnection, the patient experienced a decrease in mean arterial pressure (map) and a subsequent drop in glasgow coma scale (gcs).At the time of the event, the patient did not have an arterial line in place for continuous blood pressure monitoring.As a result, the hypotensive episode was not immediately recognized and was only identified when the non-invasive blood pressure (nibp) monitor cycled approximately 15 minutes later.There were patient involvement and no harm.
Additional Manufacturer Narrative
D4 - lot # is unknown.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.

• 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: 25512081
• Report Number: 1526863-2026-00119
• Device Sequence Number: 21455556
• Product Code: FMG
• UDI-Device Identifier: 10351688506788
• UDI-Public: (01)10351688506788
• 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): 07/17/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 07/17/2026
• 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
• Patient Sex: Unknown