CUSTOM ANGIOGRAPHIC KIT

Additional Manufacturer Narrative

THE SUSPECT MEDICAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND MICROSCOPICALLY INVESTIGATED. THE PACKAGING WAS TESTED, AND THE STERILITY WAS FOUND TO BE COMPROMISED. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE IS ATTRIBUTED TO THE MANUFACTURING PROCESS. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED. THE DEVICE WAS NOT SENT TO THE USER FACILITY.

Description of Event or Problem

THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING SEAL RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THIS WAS IDENTIFIED DURING AN INITIAL INSPECTION OF THE RECEIVED PRODUCT. THE DEVICE WAS NOT SENT TO A USER FACILITY. NO PATIENT CONTACT.