MEDEX 3-WAY STOPCOCK EXTENSION SET
Received Feb 17, 2026 · Event occurred May 2, 2025
Report 1526863-2026-00020 · MDR key 24368423
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
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.
Additional Manufacturer Narrative
H3: NO DEVICE OR DEVICE PHOTO WAS RETURNED FOR INVESTIGATION. DUE TO THIS, NO ROOT CAUSE WAS DETERMINED. THE DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.