MEDEX 3-WAY STOPCOCK EXTENSION SET
Received Feb 17, 2026 · Event occurred Dec 27, 2025
Report 1526863-2026-00030 · MDR key 24370009
Device
Generic name
Tubing, Fluid Delivery
Catalog number
MX43660
Lot number
NI
Product problems
- Break
- Fluid/Blood Leak
Patient
4 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE LINE KEPT BREAKING AND RESULTED IN BLOOD LOSS. ADDITIONAL UNSPECIFIED INTERVENTIONS AND MONITORING REQUIRED. THE EVENT OCCURRED DURING SET UP TO CHANGE THE EXTENSION THAT BROKE. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.
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.
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.