MEDEX¿ DOUBLE Y-CONNECTOR

Additional Manufacturer Narrative

TWO USED MEDEX¿ DOUBLE Y-CONNECTORS WERE RETURNED FOR INVESTIGATION. THE RETURNED DEVICES WERE RECEIVED WITHOUT PORT PROTECTORS, BUT WERE OTHERWISE ASSEMBLED ACCORDING TO THE APPROVED DRAWING. FURTHER OBSERVATION SHOWED THAT ONE VALVE WAS BROKEN INSIDE THE FEMALE LUER LOCK IN ONE OF THE DEVICES. A CAUSE FOR THE BROKEN VALVE COULD BE USING EXCESSIVE FORCE WHEN DISCONNECTING THE LINE BY USING FORCEPS, AS THE REPORTER INDICATED. THE CONNECTION BETWEEN THE VALVE AND FEMALE LUER LOCK IS SUPPOSED TO BE GLUED AS PER SPECIFICATION, WITH NO SCREWING IN AND OUT AVAILABLE. CONNECTION SHOULD BE SCREWED IN AT THE INLET SIDE OF THE VALVE. FUNCTIONAL TESTING WAS PERFORMED AND FOUND A VISIBLE LEAK FROM UNDERNEATH THE CHECK VALVE. FURTHER OBSERVATION REVEALED THIS VALVE WAS BROKEN TOO BUT IT WAS STILL POSSIBLE TO SCREW IN THE LOCK. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED A USER INTERFACE ISSUE. THE USER INTERFACED WITH THE DEVICE IN A MANNER THAT WAS INCONSISTENT WITH THE INSTRUCTIONS FOR USE.

Additional Manufacturer Narrative

SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE.

Description of Event or Problem

IT WAS REPORTED THAT A MEDEX¿ DOUBLE Y-CONNECTOR WAS ATTACHED TO A PATIENT IN THE INTENSIVE CARE UNIT FOR A PROFOFOL INFUSION WHEN IT WAS OBSERVED THAT THE CHECK VALVE STARTED TO LEAK WITHIN 24 HOURS OF USE. IT WAS NOTED THAT FORCEPS WERE USED TO DISCONNECT THE INFUSION AND THE EXTENSION, WHICH CAUSED THE BONDING MATERIAL TO LOOSEN AND DISINTEGRATE. NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00901.