MEDEX 3-WAY STOPCOCK EXTENSION SET
Received Feb 17, 2026 · Event occurred Sep 14, 2025
Report 1526863-2026-00024 · MDR key 24369022
Device
Generic name
Tubing, Fluid Delivery
Catalog number
MX43660
Lot number
NI
Product problems
- Break
- Fluid/Blood Leak
Patient
13 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6: CODES WERE UPDATED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE REPORTED COMPLAINT OF SEPARATION WAS CONFIRMED ON THE RETURNED SET. DURING VISUAL INSPECTION, THE PRESSURE TUBING WAS RECEIVED SEPARATED FROM THE MALE LUER. WHEN THE END OF THE TUBING WAS MICROSCOPICALLY EXAMINED, INSUFFICIENT SOLVENT COVERAGE WAS OBSERVED ON THE TUBING. THE PROBABLE CAUSE OF THE INSUFFICIENT SOLVENT COVERAGE ON THE TUBING HAD OCCURRED DUE TO AN ERROR DURING ASSEMBLY AT MONTERREY.
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 UNSPECIFIED INTERVENTIONS, AND REQUIRED ADDITIONAL MONITORING AND UNSPECIFIED INTERVENTIONS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.