UMBILICAL CATHETER DUAL LUMEN 5FR

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE REPORTED CONDITION WAS OBSERVED. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT WHAT USED TO BE ROUNDED EDGES AT THE END OF THE PORTS NOW HAVE (WHAT THEY WILL CALL) AS TABS ON THE RIGHT AND LEFT SIDES. IF ONE OR BOTH OF THESE TABS GETS WORN DOWN, THE STOPCOCK THAT THEY ROUTINELY CHANGE DOES NOT SCREW ON SECURELY ANYMORE, RESULTING IN PATIENT SAFETY RISK AND THE UMBILICAL LINE HAD TO BE REMOVED AND A NEW TYPE OF INTRAVENOUS ACCESS OBTAINED. THIS UMBILICAL LINE WAS ONLY IN USE FOR 5 DAYS (SHOULD LAST UP TO 14 DAYS OR LONGER) BEFORE THIS ISSUE AROSE. THERE WAS NO PATIENT HARM REPORTED.