RUSCH BRONCHOPART DOUBLE LUMEN LEFT

Description of Event or Problem

IT WAS REPORTED THAT "A PUNCTURED AND LEAKING CUFF WAS DISCOVERED AFTER INTUBATION. THE TUBE WAS REPLACED WITH A NEW ONE, BUT THE SAME PROBLEM OCCURRED. IN THE END, THREE TUBES WITH PUNCTURED CUFFS WERE USED (NOT DETECTED BEFORE INTUBATION DURING CUFF TESTING), REQUIRING AS MANY LARYNGOSCOPIES (DIRECT AND VIDEO LARYNGOSCOPE). NO PARTICULAR ANATOMICAL CONDITION OF THE PATIENT COULD EXPLAIN THIS INCIDENT". NO REPORT OF PATIENT HARM OR INJURY.

Additional Manufacturer Narrative

(B)(4).

Additional Manufacturer Narrative

QN# (B)(4). THE REPORTED COMPLAINT 'HOLE IN THE CUFF' WAS CONFIRMED BASED ON THE INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED AN ACTUAL SAMPLE FOR INVESTIGATION. VISUAL INSPECTION REVEALED A JAGGED SURFACE LONG SCRATCH AND HOLE WAS OBSERVED ON THE EXTERNAL SURFACE OF THE CUFF. THE CLEAR CUFF WAS UNABLE TO DEFLATE OR INFLATE UPON FUNCTIONAL INSPECTION DUE TO HOLE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE INVESTIGATION, THE EXACT ROOT CAUSE OF THIS REPORTED ISSUE COULD NOT BE DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT "A PUNCTURED AND LEAKING CUFF WAS DISCOVERED AFTER INTUBATION. THE TUBE WAS REPLACED WITH A NEW ONE, BUT THE SAME PROBLEM OCCURRED. IN THE END, THREE TUBES WITH PUNCTURED CUFFS WERE USED (NOT DETECTED BEFORE INTUBATION DURING CUFF TESTING), REQUIRING AS MANY LARYNGOSCOPIES (DIRECT AND VIDEO LARYNGOSCOPE). NO PARTICULAR ANATOMICAL CONDITION OF THE PATIENT COULD EXPLAIN THIS INCIDENT". NO REPORT OF PATIENT HARM OR INJURY.