UMBILICAL CATHETER SNGL LUMEN 3.5FR

Additional Manufacturer Narrative

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

Description of Event or Problem

CUSTOMER REPORTS: THE LINE WAS LEAKING FROM THE CATHETER AND BLOOD WAS BACKING UP. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 STATED THAT THE SKIN WAS CLEANED WITH BETADINE. THE DEVICE WAS SECURED WITH TEGADERM/SUTURE AND EACH LINE WAS FLUSHED WITH INFUSING FLUIDS USING SALINE WITH HEPARIN, AND A 3ML SYRINGE. THE PICC WAS REMOVED ON THE SAME DAY THAT IT WAS PLACED AND WAS SUBSEQUENTLY REPLACED WITH THE SAME TYPE OF CATHETER. THE PATIENT IS 6/7 WEEKS. THERE WAS NO SIGNIFICANT BLOOD LOSS OR SIGNS OF DISTRESS OR COMPLICATIONS. THE CURRENT STATUS OF THE PATIENT IS STABLE.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR EACH LOT AFFECTED WAS REVIEWED AND SHOWED THAT MANUFACTURING AND INSPECTION OF THE PRODUCT WAS PERFORMED AS PER APPLICABLE PROCEDURES AND VALIDATED PROCESS. ONE USED CATHETER FROM PRODUCT CODE ID 8888160333 WAS RECEIVED INSIDE OF A GENERIC PLASTIC BAG FOR ANALYSIS AND INVESTIGATION. THE VISUAL INSPECTION OF THE SAMPLE REVEALED THAT THE CATHETER SHOWED SIGNS OF USE SUCH AS RESIDUES OF BLOOD AND A HOLE WAS IDENTIFIED IN THE TUBE. ADDITIONALLY, DURING THE PHYSICAL/ FUNCTIONAL EVALUATION, THE SAMPLE WAS SUBMITTED TO UNDERWATER TESTING AND A LEAK WAS IDENTIFIED IN THE TUBE. THEREFORE, THE CONDITION REPORTED BY THE CUSTOMER WAS CONFIRMED. THE REPORTED CONDITION WAS NOT CONFIRMED AS MANUFACTURING RELATED, THEREFORE NO CORRECTIVE ACTIONS ARE REQUIRED. ACCORDING TO THE VISUAL INSPECTION OF THE DEVICE RETURNED BY THE CUSTOMER IT CAN BE DETERMINED THAT THE HOLE IS A CLEAN CUT, AS IF A SHARP OBJECT HAD BEEN USED AND CAME INTO CONTACT WITH THE DEVICE. THERE ARE NO SHARP OBJECTS USED DURING THE MANUFACTURING PROCESS THEREFORE IT IS UNCLEAR HOW THE PRODUCT CAME INTO CONTACT WITH A SHARP OBJECT. 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 AT THE PLANT. THESE PROCESSES ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.