MAUDE Adverse Event Report: ICU MEDICAL, INC. MEDEX 4-WAY STOPCOCK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MX522L
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the end of the extension tubing where the stopcock was popped off while the patient was sleeping.The operator of the device was a health professional.The report was sent to the manufacturer.The event occurred in the hospital and date of this report was on (b)(6) 2025.The event occurred while in use with patient.There was patient involvement, but no reported patient harm.
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.H3: 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.
Additional Manufacturer Narrative
H3: neither sample nor pictures were received for the analysis of this complaint.Without the return of the product a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record could not be completed as no lot number was received.

• Brand Name: MEDEX 4-WAY STOPCOCK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 24204196
• Report Number: 1526863-2026-00011
• Device Sequence Number: 5509262
• Product Code: FPA
• UDI-Device Identifier: 10351688506825
• UDI-Public: (01)10351688506825(17)280805(10)6141264
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: MX522L
• Device Lot Number: 6141264
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2025
• 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