UMBILICAL CATHETER SINGLE LUMEN 5FR

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE UMBILICAL VESSEL CATHETER (UVC) HAD A HOLE IN IT AND WAS LEAKING. THEY PLACED IT IN THE PATIENT ON (B)(6) 2022 AND SAW THAT BLOOD WAS DRIPPING FROM THE TUBING, NOT A CONNECTOR. THERE WAS NO SIGNIFICANT BLOOD LOSS AND THE DEVICE WAS IN PLACE FOR LESS THAN A DAY. A NEW UVC WAS REPLACED IMMEDIATELY AFTER INITIAL INSERTION WITHOUT ANY ADDITIONAL COMPLICATIONS. HOWEVER, THE PATIENT UNDERWENT ADDITIONAL X-RAY EXPOSURE.

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) YIELDED NO DISCREPANCIES WITHIN THE MANUFACTURE OF THE AFFECTED LOT NUMBER REPORTED. ALL QUALITY ASSURANCE TESTING PERFORMED DURING MANUFACTURING WAS ACCEPTABLE. THE QUALITY ASSURANCE REVIEW OF THE VISUAL, PHYSICAL, AND DIMENSIONAL EVALUATION RESULTS INDICATED THAT THE PRODUCT MET SPECIFICATION REQUIREMENTS. IN ADDITION, ALL DHRS ARE REVIEWED TO CONFIRM ALL REGULATORY REQUIREMENTS PRIOR TO PRODUCT RELEASE. ONE USED CATHETER FROM LOT NUMBER 1803800115 AND PRODUCT CODE ID 8888160341 WAS RECEIVED INSIDE OF A GENERIC PLASTIC BAG WITH ITS ORIGINAL SEALED PACKAGE. ACCORDING TO THE TEST PERFORMED ON THE DEVICE, THE CATHETER DID SHOWED SIGNS OF USE SUCH AS BLOOD RESIDUE. THE PHYSICAL SAMPLE EVALUATION REVEALED THAT THE SAMPLE PASSED THE LEAK TEST DURING UNDERWATER TESTING, THEREFORE, NO DEFICIENCY WAS IDENTIFIED. THE CUSTOMER REPORTED EVENT WAS NOT CONFIRMED BASED ON THE VISUAL AND FUNCTIONAL EVALUATION. A CHANGE WAS MADE TO CHANGE OF DESIGN OF THE CATHETER AND A FORMAL CORRECTIVE/PREVENTATIVE ACTION WAS OPENED AFTER THE REPORTED LOT WAS MANUFACTURED. CUSTOMER PERCEPTION IS DETERMINED AS THE MOST PROBABLE ROOT CAUSE BASED ON THE INVESTIGATION AS THERE ARE CONTROLS IN PLACE TO DETECT THIS TYPE OF CONDITION SUCH AS LEAK TEST AND 100% OCCLUSION TESTS. BASED ON THE AVAILABLE INFORMATION, IT CAN BE CONCLUDED THAT PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. 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 PERFORMED IN THE PLANT ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.