MAUDE Adverse Event Report: ICU MEDICAL ASD, INC. MEDEX HI-FLO 4-WAY STOPCOCK W/SWIVEL MALE LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	MX9341L
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that there was blood noted and vasopressor medication leaking from stopcock bridge attached to cvc lumen.The connections were checked and tightening attempted.It continued to leak and back flowed blood.Manifold quickly primed and medications reattached.The patient was on multiple vasopressor infusions to maintain blood pressure.Following product failure, the patient (critically ill and admitted to a critical care unit) had a substantial drop in blood pressure and the rn noted that blood and medications were leaking from the stopcock.No attempt to mitigate the ligate was successful so the rn switched to a different brand¿s manifold.Blood pressure was managed with emergency medications such as phenylephrine until the vasopressor infusions could be re-established through the manifold.This was a peri- cardiac arrest situation.There was patient involvement and harm reported.

• Brand Name: MEDEX HI-FLO 4-WAY STOPCOCK W/SWIVEL MALE LUER LOCK
• 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: 24839352
• Report Number: 1526863-2026-00090
• Device Sequence Number: 21230988
• Product Code: FMG
• UDI-Device Identifier: 10351688504173
• UDI-Public: (01)10351688504173
• 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): 07/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MX9341L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown