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

Catalog Number	MX43660
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the tubing on the stopcock snapped.The patient experienced bleeding from the arterial line as a result of this defective product.The event occurred while in use with patient.There was no reported patient harm.
Additional Manufacturer Narrative
H3: the device was received for evaluation with the tubing separated from the male luer, which was not returned.No manufacturing anomalies were identified in the lot history review.Visual inspection confirmed the separation with adequate adhesive coverage observed on the tubing.Functional testing showed the bond strength met specification, indicating no adhesive deficiency.The complaint of separation was confirmed; however, the root cause could not be determined due to the missing component.

• Brand Name: MEDEX 3-WAY STOPCOCK EXTENSION SET
• Common Device Name: TUBING, FLUID DELIVERY
• 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: 24146350
• Report Number: 1526863-2026-00007
• Device Sequence Number: 8887805
• Product Code: FPK
• UDI-Device Identifier: 10351688507563
• UDI-Public: (01)10351688507563(17)281020(10)6152632
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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
• Device Lot Number: 6152632
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 04/15/2026
• 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