MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHECK VALVE WITH MALE/FEMALE LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	011-CS25
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Adult Respiratory Distress Syndrome (1696)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved an anti-reflux valve (check valve with male/female luer lock) leak when in use with a central venous catheter (cvc).This caused all the patient's (unspecified) sedation medications to leak on to the bed.The patient was intubated, sedated, and under muscle relaxants, in the prone position because she was in severe respiratory distress.Suddenly, she began to raise her head.The clinician reacted immediately by securing her and notifying the doctor.All the tubing was changed as a precaution for this instance.The patient was in danger.She was improperly sedated, resulting in uncontrolled respiratory distress.Actions taken at the healthcare facility for patient management: duty physician and management were notified.This report captures first of two occurrences for the patient.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.

• Brand Name: CHECK VALVE WITH MALE/FEMALE LUER LOCK
• 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: 24603180
• Report Number: 9617594-2026-00274
• Device Sequence Number: 15545234
• Product Code: FMG
• UDI-Device Identifier: 00840619006075
• UDI-Public: (01)00840619006075(17)300701(10)14505009
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: Health Professional
• Device Catalogue Number: 011-CS25
• Device Lot Number: 14505009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTRAL VENOUS CATHETER (CVC), UNK MFR; UNSPECIFIED SEDATIVE DRUG, UNK MFR
• Patient Sex: Unknown