MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V MEDEX 4-WAY STOPCOCK EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MX6812
Medical Device Problem Codes	Leak/Splash (1354); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: year of event and month has been provided; day is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that they have the same issue with four-way stopcock extension which they were easily able to disconnect the two pieces, and they are used on pressurized arterial lines in which they can lose large volumes of blood if not caught in time.There is no reported patient involvement.
Additional Manufacturer Narrative
No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Additional Manufacturer Narrative
H3/h6: one used device was returned for investigation.The device was visually inspected.It was observed that the tubing p/n 105c-09 was separated from the male luer lock p/n 500-017.It was observed that the tubing p/n 105c-09 was separated from the male luer lock p/n 500-017.The functional and dimensional testing was performed.Resulting in the tubing pulled off at 15.2 lbs which is within the specification limit of 6lbs.The outer diameter of the tubing was within the specification.The reported problem was confirmed since in the images shared by customer a disconnection was observed between tubing p/n 105c-09 and component pn 500-017.The cause for the disconnection between the tubing p/n 105c-09 and male luer lock p/n 500-017 is unknown.The device history record was unable to be reviewed as no lot number was provided.

• Brand Name: MEDEX 4-WAY STOPCOCK EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 23393674
• Report Number: 1526863-2025-00124
• Device Sequence Number: 15964422
• Product Code: FPA
• UDI-Device Identifier: 10351688506054
• UDI-Public: (01)10351688506054
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2026

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: MX6812
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 03/03/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/22/2025; 03/04/2026
• 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
• Patient Sex: Unknown