SUGAN CO., LTD..OSAKA..JP.ETO.CUSTOM ANGIOGRAPHIC KIT.

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED UNIT FOUND THE PACKAGING TO BE UNOPENED AND IN GOOD CONDITION. UPON EXAMINING THE BLUE STRIPED TUBING IN QUESTION, A FOREIGN OBJECT WAS ABLE TO BE CONFIRMED LOOSE WITHIN THE FLUID PATHWAY. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE IS ATTRIBUTABLE TO THE ENVIRONMENT IN WHICH THE PRODUCT IS MANUFACTURED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE PRODUCT HISTORY WAS REVIEWED, AND NO DEVIATIONS, NON-CONFORMANCES, OR EXCEPTION DOCUMENTS WERE FOUND. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A RED FOREIGN OBJECT IN THE BLUE STRIPED TUBE.