MEDEX 3-WAY STOPCOCK EXTENSION SET

Additional Manufacturer Narrative

COMPLAINT FOR THE FAILURE MODE ¿LINE CLEAR TUBING DISCONNECTED OR DISLODGED (SEPARATION)¿ COULD NOT BE CONFIRMED AS NO SAMPLES NOR PICTURES WERE PROVIDED BY THE CUSTOMER.WITHOUT THE RETURN OF A PHYSICAL SAMPLE OF THIS COMPLAINT, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. LOT NUMBER WAS NOT PROVIDED THEREFORE LOT HISTORY REVIEW CANNOT BE PERFORMED.

Description of Event or Problem

IT WAS REPORTED THAT A LINE CLEAR TUBING DISCONNECTED OR DISLODGED FROM WHERE IT WAS GLUED INTO THREE-WAY STOPCOCK ON THE PATIENT SIDE. NURSE AT THE TIME OF EVENT CLAMPED LINE QUICKLY AFTER NOTING BLEEDING. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.