MEDEX FOUR-WAY STOPCOCK EXTENSION

Description of Event or Problem

IT WAS REPORTED THAT THE PRODUCT WAS CONNECTED TO AN ARTERIAL LINE TUBING AND WAS BEING USED ON A PATIENT. THE EXTENSION TUBING BROKE OFF AT THE STOPCOCK CONNECTION. THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF PATIENT HAD HARM OR AN ADVERSE EVENT OCCURRED.

Additional Manufacturer Narrative

DATE OF EVENT IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. DEVICE HAS NOT BEEN RETURNED TO DATE. 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

DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED. THE PRODUCT WAS VISUALLY INSPECTED UNDER A MICROSCOPE AND IT WAS OBSERVED THAT TUBE EXHIBITED SOLVENT BONDING SIGNATURE. THE SOLVENT SIGNATURE OF THIS PIECE WAS COMPARED AGAINST THE RETURNED SAMPLE AND IT WAS OBSERVED THAT THE SOLVENT LENGTH AND SIGNATURE MARK WERE SIMILAR. THEREFORE, IT WAS CONCLUDED THAT THE SOLVENT BONDING PROCESS OF THE COMPONENT FROM THE RETURNED SAMPLE WAS EXECUTED CORRECTLY. THE DEVICE HISTORY RECORD OF THE REPORTED LOT WAS REVIEWED AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION.