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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
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 reportable information becomes available.
Event or Problem Description
It was reported that a patient was found to have blood leaking onto pillow by the rn.When traced back it was found that iv fluid and blood was coming from cracked stopcock where needleless luer lock device connects into.The setup was quickly changed, and within 10 minutes the same thing was witnessed to be happening, the stopcock was cracked where the luer lock connects into.This was again changed, and within 5 minutes blood and iv gtt started leaking out of the cracked stopcock.This happened a total of four times, eventually the iv tubing was connected directly to the stopcock, no further leaking or back up of blood occurred.There was a patient involvement and there was no patient harm.

• 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: 25137248
• Report Number: 1526863-2026-00108
• Device Sequence Number: 21163426
• Product Code: FMG
• UDI-Device Identifier: 10351688504173
• UDI-Public: (01)10351688504173(17)280922(10)6152762
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: MX9341L
• Device Lot Number: 6152762
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2025
• 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