MEDEX 3-WAY STOPCOCK EXTENSION SET

Additional Manufacturer Narrative

NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS STATED THAT THE LINE KEPT BREAKING AND RESULTED IN BLOOD LOSS. THE EVENT OCCURRED DURING INFUSION AND MONITORING. THE EVENT OCCURRED AT CTICU. THERE WERE ADDITIONAL INTERVENTIONS AND MONITORING REQUIRED. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

Additional Manufacturer Narrative

H6: CODES WERE UPDATED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE REPORTED COMPLAINT SEPARATION WAS CONFIRMED. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED DURING VISUAL INSPECTION, THE PRESSURE TUBING WAS RECEIVED SEPARATED FROM THE MALE LUER OF THE STOPCOCK. WHEN THE END OF THE TUBING WAS MICROSCOPICALLY EXAMINED, THERE WAS INSUFFICIENT SOLVENT COVERAGE AROUND THE TUBING. THE PROBABLE CAUSE OF THE SEPARATION HAD OCCURRED DUE TO AN ERROR DURING ASSEMBLY A MONTERREY.