TRACHEAL TUBE, CUFFED, ORAL PREFORMED

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED "THE CUFF COULD NOT BE INFLATED. THE BLUE CUFF MONITOR BALLOON IS PROBABLY STUCK. WE USED ANOTHER TUBE, WHICH WORKED. AFTER MANY ATTEMPTS AND OVERCOMING RESISTANCE, THE CUFF WAS FINALLY INFLATED WITH SOME DIFFICULTY". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

Description of Event or Problem

IT WAS REPORTED "THE CUFF COULD NOT BE INFLATED. THE BLUE CUFF MONITOR BALLOON IS PROBABLY STUCK. WE USED ANOTHER TUBE, WHICH WORKED. AFTER MANY ATTEMPTS AND OVERCOMING RESISTANCE, THE CUFF WAS FINALLY INFLATED WITH SOME DIFFICULTY". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

Additional Manufacturer Narrative

(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.