(B)(4). TELEFLEX HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE DETAILS OF THE EVENT AND THE PATIENT'S SYMPTOMS AND CURRENT CONDITION. TO DATE, NO RESPONSE HAS BEEN RECEIVED. A VISUAL INSPECTION OF PHOTOS SUBMITTED WITH THE CUSTOMER COMPLAINT SHOWED WHAT APPEARED TO BE THE COATING OF ONE STYLET PRODUCT. THE COATING WAS CONFIRMED TO BE BROKEN IN THE PHOTOS. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE DEVICE COULD NOT BE CONDUCTED SINCE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. THE HOSPITAL HAS STATED THEY "CANNOT BE SURE IF IT IS POSSIBLE TO OBTAIN". A DEVICE HISTORY RECORD INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT DESCRIPTION. CUSTOMER COMPLAINT IS CONFIRMED VIA PHOTOGRAPHS. HOWEVER, IT IS NECESSARY TO RECEIVE THE PHYSICAL DEVICE SAMPLE TO PERFORM A PROPER INVESTIGATION, DETERMINE A ROOT CAUSE AND IMPLEMENT NECESSARY CORRECTIVE ACTIONS. A CONCLUSION CODE COULD NOT BE CHOSEN AS THE COMPLAINT WAS CONFIRMED, HOWEVER A ROOT CAUSE COULD NOT BE DETERMINED. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE, THIS REPORT WILL BE UPDATED ACCORDINGLY.
D
Patient 1
A REPORT WAS RECEIVED FROM A CUSTOMER IN (B)(6) THAT "A (B)(6) OLD CHILD WAS INTUBATED IN A PROCEDURE IN (B)(6). AFTER BEING DISCHARGED FROM THE HOSPITAL SHE HAD STILL RESPIRATORY PROBLEMS. AFTER 2 MONTHS SHE WAS HOSPITALIZED AGAIN AND THE SURGEON MADE A BRONCHOSCOPY WHERE THEY FIND 11 CM COATING FROM THE PRODUCT IN THE AIRWAYS."
N
Patient 1
(B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. THE CUSTOMER ONLY RETURNED A PIECE OF THE COATING FOR THE STYLET. THE STYLET WAS NOT RETURNED. VISUAL EXAMINATION OF THE RETURNED SAMPLE REVEALED THAT THE SAMPLE APPEARS TO BE CUT ON ONE END. THE PIECE OF COATING THAT WAS RETURNED IS APPROXIMATELY 11.5CM LONG. SINCE THE REST OF THE DEVICE WAS NOT RETURNED, IT COULD NOT BE DETERMINED HOW THE PIECE OF COATING FELL OFF OF THE STYLET. THE SAMPLE APPEARS TO BE USED AS THERE IS BIOLOGICAL MATERIAL PRESENT ON THE DEVICE. THE REPORTED COMPLAINT ISSUE OF "COATING HAS SHEARED FROM STYLET" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. ONLY AN APPROXIMATELY 11.5CM PIECE OF THE COATING WAS RETURNED. THE REST OF THE DEVICE WAS NOT RETURNED. SINCE THE REST OF THE DEVICE WAS NOT RETURNED, IT COULD NOT BE DETERMINED HOW THE PIECE OF COATING FELL OFF OF THE STYLET. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE ROOT CAUSE OF THIS COMPLAINT ISSUE COULD NOT BE DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON THIS COMPLAINT ISSUE.
D
Patient 1
A REPORT WAS RECEIVED FROM A CUSTOMER IN DENMARK THAT "A (B)(6) CHILD WAS INTUBATED IN A PROCEDURE IN APRIL. AFTER BEING DISCHARGED FROM THE HOSPITAL SHE HAD STILL RESPIRATORY PROBLEMS. AFTER 2 MONTH SHE WAS HOSPITALISED AGAIN AND THE SURGEON MADE A BRONCHOSCOPY WHERE THEY FIND 11 CM COATING FROM THE PRODUCT IN THE AIRWAYS."