UMBILICAL CATHETER SNGL LUMEN 2.5FR

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THE SR. WAS ATTEMPTING TO FLUSH THE CATHETER, BUT THE CATHETER SEEMED TO BE BLOCKED. THEY WERE UNABLE TO USE SAID CATHETER. THE CATHETER WAS NOT INSERTED, THEY FOUND THE BLOCKAGE BEFORE IT WAS INSERTED.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. THE ACTUAL SAMPLE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION NOR WERE ANY PHOTOS OR VIDEOS RECEIVED. CONSEQUENTLY, IT WAS NOT POSSIBLE TO EVALUATE A SAMPLE AS PART OF A COMPREHENSIVE FAILURE INVESTIGATION. HOWEVER, IT IS IMPORTANT TO NOTE THAT CORRECTIVE AND PREVENTATIVE ACTIONS WERE IMPLEMENTED AFTER THE MANUFACTURE OF THE REPORTED LOT TO ADDRESS THE REPORTED CONDITION. IF A SAMPLE IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND THE INVESTIGATION WILL BE UPDATED ACCORDINGLY. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

Additional Manufacturer Narrative

ONE USED CATHETER WAS RECEIVED FOR THE INVESTIGATION. THE SAMPLE WAS INSPECTED, AND THE REPORTED CONDITION WAS CONFIRMED; A MATERIAL WAS FOUND INSIDE THE TIP OF THE CATHETER OBSTRUCTING THE FLOW PATH. FURTHER TESTING SHOWED THAT THE OCCLUSION IS NOT A FOREIGN PARTICLE, IT¿S PART OF THE TUBE MATERIAL. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THE REPORTED CONDITION. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.