UMBILICAL CATHETER SNGL LUMEN 3.5FR

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE LEAKING WAS IDENTIFIED AT THE JUNCTION BETWEEN THE HUB AND THE TUBING WHEN IT WAS USED ON THE PATIENT AROUND 20 MINUTES. PER ADDITIONAL INFORMATION RECEIVED 21JUN2022, THEY SWITCHED AND STOPPED USING THE CATHETER AND THEY PASSED THE CATHETER TO THEIR SALES PEOPLE FOR FURTHER INVESTIGATION PROCESS. THE LEAKING OCCURRED JUST BELOW THE MOLDED STRAIN RELIEF ON THE EXTENSIONS. THE CATHETER WAS NOT DIFFICULT TO HANDLE DURING INSERTION.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

EVALUATION SUMMARY: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWED THAT THE LOT WAS MANUFACTURED ACCORDING TO STANDARDS AND THAT THERE WERE NO DISCREPANCIES THAT COULD BE RELATED TO THE EVENT REPORTED. BASED ON REVIEW, IT IS CONCLUDED THAT THE LOT WAS RELEASED ACCORDING TO PRODUCT REQUIREMENTS. ONE CATHETER WAS RECEIVED FOR ANALYSIS AND INVESTIGATION. ACCORDING TO THE VISUAL INSPECTION THE CATHETER DID NOT SHOW SIGNS OF USE. THE PHYSICAL SAMPLE EVALUATION REVEALED THAT THE CATHETER PASSED THE LEAK TEST PERFORMED. THE DEVICE DID NOT SHOW BUBBLES DURING UNDERWATER TESTING. THE REPORTED CONDITION COULD NOT BE CONFIRMED. THERE ARE CONTROLS IN PLACE AT THE MANUFACTURING SITE TO DETECT THIS TYPE OF FAILURE MODE SUCH AS LEAK TESTING AND 100% OCCLUSION TESTS. IT MUST BE NOTED THAT IN-PROCESS CONTROLS, SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.