MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX 3-WAY STOPCOCK EXTENSION SET; TUBING, FLUID DELIVERY

Catalog Number	MX43660
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint for the failure mode ¿line clear tubing disconnected or dislodged (separation)¿ could not be confirmed as no samples nor pictures were provided by the customer.Without the return of a physical sample of this complaint, a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.Lot number was not provided therefore lot history review cannot be performed.
Event or Problem Description
It was reported that a line clear tubing disconnected or dislodged from where it was glued into three-way stopcock on the patient side.Nurse at the time of event clamped line quickly after noting bleeding.The event occurred while in use with patient.There was patient involvement and no reported patient harm.

• Brand Name: MEDEX 3-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 ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24111455
• Report Number: 1526863-2026-00006
• Device Sequence Number: 10394187
• Product Code: FPK
• UDI-Device Identifier: 10351688507563
• UDI-Public: (01)10351688507563
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2026

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: MX43660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 01/19/2026
• 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