MEDEX 3-WAY STOPCOCK EXTENSION SET

Additional Manufacturer Narrative

THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 3012307300-2025-02039. THE DATE OF THAT SUBMISSION WAS 2/19/2025. DEVICE EVALUATION: ONE UNIT (STOPCOCK) OUTSIDE ITS ORIGINAL PACKAGE WITHOUT IDENTIFICATION OF PART NUMBER AND LOT NUMBER WAS RECEIVED. THE UNIT RECEIVED (STOPCOCK) WAS COMPARED VERSUS DRAWING OF THE REPORTED PART NUMBER. IT WAS OBSERVED THAT THE PART NUMBER RECEIVED DID NOT BELONG TO THE REPORTED PART NUMBER. COMPARING THE STOPCOCK RECEIVED VERSUS THE DRAWING OF THE REPORTED PART NUMBER, IT WAS NOTICED THAT THERE WAS NOT A TUBE ASSEMBLED. ALSO, THE STOPCOCK RECEIVED HAS ASSEMBLED A LOCK NUT AND TWO BLUE COMPONENTS WHICH ARE NOT USED TO ASSEMBLE THE REPORTED PART NUMBER. THE COMPLAINT CANNOT BE CONFIRMED BECAUSE THE SAMPLE RECEIVED DOES NOT BELONG TO THE REPORTED PART NUMBER. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN.

Description of Event or Problem

IT WAS REPORTED THAT AFTER APPROXIMATELY ONE HOUR OF INFUSION, THE NURSE NOTED THE 3-WAY STOP COCK TO BE CRACKED ON THE LEVOPHED SIDE. PATIENT WAS NOTED TO HAVE HEMODYNAMIC INSTABILITY WHICH REQUIRED FREQUENT TITRATION UP AND DOWN OF LEVOPHED. THERE WERE UNKNOWN PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.