PORTEX TUBES BLUSELECT SUCTIONAID

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 INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT DURING A ROUTINE ASSESSMENT, THE CUFF WAS FOUND TO HAVE DEFLATED TO APPROXIMATELY 10¿15 CMH2O PRESSURE, DESPITE BEING INFLATED EARLIER IN THE SHIFT. A TRACHEOSTOMY TUBE CHANGE WAS PERFORMED DUE TO CONCERNS ABOUT POTENTIAL SILENT ASPIRATION. THE EXISTING PORTEX 7.0 CUFFED SUCTION TRACHEOSTOMY TUBE WAS REPLACED WITH A SIMILAR-SIZED TUBE. THE EVENT OCCURRED DURING THE TRACHEOSTOMY ROUND.

Additional Manufacturer Narrative

ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT CONFIRM THE REPORTED ISSUE. FUNCTIONAL TESTING WAS PERFORMED, AND IT WAS CONFIRMED THAT AFTER 12 HOURS THE CUFF WAS STILL FULLY INFLATED. BASED ON RESULTS OF TESTING, THE REPORTED FAILURE WAS NOT CONFIRMED. NO TREND OF SIMILAR CUSTOMER COMPLAINTS WAS IDENTIFIED THROUGH A LOT OF HISTORY OR DEVICE HISTORY REVIEW.