PORTEX TUBES BLUSELECT SUCTIONAID

Additional Manufacturer Narrative

DEVICE EVALUATION: ONE DEVICE WAS RECEIVED FOR DEVICE ANALYSIS. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING AND VISUAL INSPECTION PERFORMED DURING ANALYSIS. THE CUSTOMER REPORTED COMPLAINT COULD NOT BE CONFIRMED OR REPLICATED. THE PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED.

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE CUFF PRESSURE COULD NOT BE KEPT. THERE WAS A POSSIBILITY OF AN AIR LEAK. THE EVENT OCCURRED DURING THE PATIENT USE, AND NO ADVERSE EVENT.