MEDEX 3-WAY STOPCOCK EXTENSION SET
Received Feb 17, 2026 · Event occurred May 5, 2025
Report 1526863-2026-00021 · MDR key 24368482
Device
Generic name
Tubing, Fluid Delivery
Catalog number
MX43660
Lot number
NI
Product problems
- Break
- Fluid/Blood Leak
Patient
12 MO · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6: CODES WERE UPDATED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE REPORTED COMPLAINT SEPARATION WAS CONFIRMED. DURING VISUAL INSPECTION, THE PRESSURE TUBING WAS RECEIVED SEPARATED FROM THE FEMALE LUER OF THE STOPCOCK. WHEN THE END OF THE TUBING WAS MICROSCOPICALLY EXAMINED, THERE WAS GOOD SOLVENT COVERAGE AROUND THE TUBING. THE PROBABLE CAUSE OF THE SEPARATION IS UNKNOWN.
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE LINE REPEATEDLY BROKE, RESULTING IN BLOOD LOSS. THE EVENT OCCURRED DURING INFUSION, MONITORING, AND INTERVENTIONS, AND REQUIRED ADDITIONAL MONITORING AND INTERVENTIONS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.