UMBILICAL CATHETER SINGLE LUMEN 5FR

Description of Event or Problem

THE CUSTOMER REPORTED THE RN WAS ATTEMPTING TO REMOVE THE UVC CATHETER THAT WAS PLACED AT 10CM. THE DRESSING WAS REMOVED, AND THE SUTURES WERE LOOSENED WITH USE OF THE TWEEZERS AND SCISSORS IN THE SUTURE KIT. THE RN STABILIZED THE BASE OF THE CORD WITH THE LEFT HAND AND USED THE TWEEZERS FROM THE SUTURE KIT TO BEGIN REMOVING THE CATHETER SLOWLY WITH THE RIGHT HAND. THE CATHETER CAME OUT EASILY UNTIL THE 6.5CM MARK. THE LINE THEN BROKE OFF SUDDENLY. MINIMAL TENSION HAD BEEN USED WHILE REMOVING THIS LINE. THE LINE WAS STICKING OUT OF THE UMBILICUS. THE RN QUICKLY CLAMPED THE LINE WITH THE SAME HAND USED TO STABILIZE THE BASE, AND THEN CALLED THE CHARGE RN FOR ASSISTANCE. THE BASE OF THE LINE WAS CLAMPED. THEY THEN REMOVED THE REMAINDER OF THE LINE WITH ASSIST FROM THE RESOURCE RN. THE CATHETER WAS COMPLETE FOR A TOTAL OF 10CM. HOMEOSTASIS WITHIN NORMAL TIME FRAME AND GAUZE DRESSING WAS APPLIED TO THE SITE.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) REVIEW SHOWED THE LOT WAS MANUFACTURED ACCORDING TO STANDARDS AND THAT THERE WERE NO DISCREPANCIES THAT COULD BE RELATED TO THE EVENT REPORTED. THE ACTUAL SAMPLE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION, PICTURES OR VIDEOS WERE RECEIVED. NO ACTIONS ARE REQUIRED AT THIS TIME AS THE DEFECT CANNOT BE CONFIRMED AS MANUFACTURING RELATED. IT WAS NOT POSSIBLE TO DETERMINE A ROOT CAUSE. IF A SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.