inforMED
MalfunctionFPK

MEDEX 3-WAY STOPCOCK EXTENSION SET

Received Jan 26, 2026 · Event occurred Dec 27, 2025

Report 1526863-2026-00009 · MDR key 24184402

Device

Generic name

Tubing, Fluid Delivery

Catalog number

MX43660

Lot number

NI

Product problems

  • Fluid/Blood Leak
  • Fracture

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

NO PRODUCT OR PHOTOS WERE RETURNED THEREFORE NO DEVICE ANALYSIS COULD BE COMPLETED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.

Description of Event or Problem

IT WAS REPORTED THAT UPON INSPECTION IT WAS NOTICED THE ACTUAL A-LINE TUBING WAS LEAKING SMALL AMOUNT OF BLOOD. WHILE CHANGING THE TUBING, THE TUBING COMPLETELY RIPPED IN HALF. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AND NO REPORTED PATIENT HARM.