PRESSURE MONITORING ACCESSORY

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

Description of Event or Problem

IT WAS REPORTED THAT AFTER THE DEVICE WAS USED ON A PATIENT, AN UNKNOWN PAPER-LIKE MATERIAL WAS FOUND IN THE FEMALE CONNECTOR OF THE PRESSURE MONITORING KIT. THERE WAS NO ALLEGATION OF PATIENT INJURY.