MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX 4-WAY STOPCOCK EXTENSION SET; TUBING, FLUID DELIVERY

Catalog Number	MX43860
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event 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 are continuing to have issues with arterial line extension tubing disconnections.They were easily able to disconnect the two pieces, and they are used on pressurized arterial lines where patients can lose large volumes of blood if not caught in time.There is patient involvement as it was used on patients with pressurized arterial lines.There was no patient harm reported.
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.

• Brand Name: MEDEX 4-WAY STOPCOCK EXTENSION SET
• Common Device Name: TUBING, FLUID DELIVERY
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6250 shier rings road; ni; dublin, OH 43016 ; 2247062300
• MDR Report Key: 23430070
• Report Number: 1526863-2025-00126
• Device Sequence Number: 12806670
• Product Code: FPK
• UDI-Device Identifier: 10351688507532
• UDI-Public: (01)10351688507532(17)280210(10)6091295
• 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
• Report Date (Section B): 12/22/2025

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: MX43860
• Device Lot Number: 6091295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• 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