ESOPHAGEAL BOUGIES

Additional Manufacturer Narrative

(B)(4). THE FACILITY HAS COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. A VISUAL NOR FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. NO ADDITIONAL TESTS OR INSPECTIONS WERE CONDUCTED SINCE PRODUCT CODE 507940 WAS NOT IN PRODUCTION. A COMPLAINT HISTORY REVIEW WAS CONDUCTED ON THE CATALOG NUMBER IN QUESTION FROM 13-JAN-2019 TO 20-JAN-2020. NO COMPLAINTS WERE RECEIVED IN THIS RANGE WITH THE SAME ISSUE. A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. A CORRECTIVE ACTION COULD NOT BE CONDUCTED DUE TO THE LACK OF PRODUCT SAMPLE AND BATCH NUMBER TO PERFORM A PROPER INVESTIGATION TO DETERMINE A ROOT CAUSE. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OR PRODUCT SAMPLE AND BATCH NUMBER TO PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

Description of Event or Problem

THE REPORT STATES: AT 9AM (B)(6) THAT A BOUGIE HAD BURST INSIDE A PATIENT IN THE OR. CATALOG '507940. BOUGIE WITH TUNGSTEN-FILLED POWDER AND WAS EXPIRED. FURTHER INFORMATION INDICATES THE FOLLOWING: NO NOTED CHANGE IN THE PATIENT'S CONDITION AND NO INJURY. THE AREA WAS IRRIGATED. THE DEVICE WAS BEING USED AS A DILATOR. THE EXPIRATION DATE IS UNKNOWN.