MEDEX 3-WAY STOPCOCK EXTENSION SET
Received Feb 17, 2026 · Event occurred Dec 21, 2025
Report 1526863-2026-00027 · MDR key 24369636
Device
Generic name
Tubing, Fluid Delivery
Catalog number
MX43660
Lot number
NI
Product problems
- Break
- Fluid/Blood Leak
Patient
7 YR · 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 AND MONITORING AND REQUIRED ADDITIONAL MONITORING AND UNSPECIFIED INTERVENTIONS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.
Additional Manufacturer Narrative
H6: CODES WERE UPDATED. NO DEVICE WAS RECEIVED FOR INVESTIGATION. THEREFORE, THE REPORTED COMPLAINT IS UNABLE TO BE CONFIRMED. IF THE DEVICE IS RECEIVED, THE INVESTIGATION WILL BE RE-OPENED FOR FURTHER EVALUATIONS. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER.