3.5FR DUAL-LUMEN UVC CATH

Additional Manufacturer Narrative

THERE WAS NO LOT NUMBER IDENTIFIED, THEREFORE A MANUFACTURING DEVICE HISTORY REVIEW OR PRODUCT/PROCESS CHANGES REVIEW FOR THE INVOLVED LOT NUMBER COULD NOT BE PERFORMED. HOWEVER, ALL DEVICE HISTORY RECORDS ARE REVIEWED TO MEET REGULATORY REQUIREMENTS PRIOR TO PRODUCT RELEASE. ALL QUALITY ASSURANCE TESTS PERFORMED DURING MANUFACTURING ARE REVISED TO MEET REGULATORY REQUIREMENTS. THE QUALITY ASSURANCE REVIEW INCLUDES THE VISUAL, PHYSICAL, AND DIMENSIONAL EVALUATION. ONE USED CATHETER FROM AN UNKNOWN LOT NUMBER WAS RECEIVED INSIDE OF A GENERIC PLASTIC BAG FOR ANALYSIS AND INVESTIGATION. ACCORDING TO THE VISUAL INSPECTION AND TESTING, THE CATHETER WAS USED AS VISIBLE RESIDUES OF BLOOD WAS IDENTIFIED AND IT HAD TWO ADAPTORS THAT DO NOT BELONG TO THE ORIGINAL PRODUCT. THE SAMPLE WAS SUBMITTED TO UNDERWATER TESTING AND A LEAK WAS IDENTIFIED FROM AN IRREGULAR CUT ON THE TUBING. THE EVENT REPORTED WAS CONFIRMED. THE MOST PROBABLE ROOT CAUSE FOR LEAKING, MAY OCCUR DURING USE OF THE PRODUCT. BASED ON INSTRUCTIONS FOR USE THE CATHETER SHOULD BE FLUSHED AND FILLED WITH HEPARINIZED SALINE PRIOR TO USE. ACCORDING TO THE EVENT DESCRIPTION THAT THE UMBILICAL VENOUS CATHETER (UVC) WAS FOUND TO BE LEAKING. AS REPORTED THE LINE WAS REMOVED AND REPLACED, THE DEVICE WAS ALREADY BEING USED ON THE PATIENT. BASED ON THIS IT CAN BE CONCLUDED THAT WHEN FLUSHING THE DEVICE PRIOR TO INSERTING IT TO THE PATIENT, IT DID NOT SHOW LEAKING, MEANING THAT THE DEVICE WAS IN GOOD CONDITIONS PRIOR TO USE. ACCORDING TO THE COMPLAINT HANDLING PROCEDURE A FORMAL CORRECTIVE/PREVENTATIVE ACTION WAS NOT REQUIRED BASED ON THE CARDINAL HEALTH DISTRIBUTED PRODUCT FIELD ACTION ASSESSMENT (DPFA) AND THE PROBABILITY OCCURRENCE CALCULATED FOR THIS ISSUE IS REMOTE. 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.

Description of Event or Problem

CUSTOMER REPORTS: THE UMBILICAL VENOUS CATHETER (UVC) WAS FOUND TO BE LEAKING. THE LINE REMOVED AND REPLACED WITH A PICC. THE REPORTER DID NOT DOCUMENT WHERE THE LEAK WAS NOTED OTHER THAN THE SECUREMENT TAPES WERE WET AND DECISION WAS MADE TO REPLACE THE LINE.