PORTEX TUBES BLUSELECT SUCTIONAID

Additional Manufacturer Narrative

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 STATED THAT DURING THE SURGICAL TRACHEOSTOMY PROCEDURE, THE CUFF BALLOON RUPTURED IN TWO CANNULAS SUCCESSIVELY, WITHOUT ANY PERCEPTIBLE CAUSE. THE EVENT WAS DETECTED DURING CLINICAL USE, AND THE CUSTOMER CLASSIFIED THE INCIDENT AS A RUPTURE. THERE WAS NO PATIENT HARM.

Additional Manufacturer Narrative

THREE IMAGES WERE PROVIDED BY THE CUSTOMER SHOWING TWO TRACH TUBES WITH RUPTURED CUFFS. THE COMPLAINT OF CUFF DAMAGE CAN BE CONFIRMED BASED ON THE RETURNED IMAGES. THE PROBABLE CAUSE IS UNKNOWN. WITHOUT THE RETURN OF THE USED SAMPLE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. A DEVICE HISTORY REVIEW WAS PERFORMED AND FOUND NO NON-CONFORMANCES.