HUDSON BREATHING BAG,2 LITER,LATEX FREE

Additional Manufacturer Narrative

QN# (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT WAS PERFORMED ON A PICTURE RECEIVED BY THE CUSTOMER OF PRODUCT CODE 5432 (BREATHING BAG, 2 LITER, LATEX FREE). THE CUSTOMER DESCRIPTION STATES, "DURING THE VENTILATION TO THE PATIENT, THEY REALIZED THAT THERE WAS A LEAK IN THE SYSTEM AND OBSERVED THAT THE BREATHING BAG HAD A HOLE". DURING THE VISUAL INSPECTION AGAINST RECEIVED PICTURE REPORTED BY CUSTOMER, THE HOLE IS NOT VISIBLE AS DESCRIBED ON THIS CUSTOMER COMPLAINT. SAMPLE NEEDS TO BE EVALUATED TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. 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.

Description of Event or Problem

IT WAS REPORTED "DURING THE VENTILATION TO THE PATIENT, THEY REALIZED THAT THERE WAS A LEAK IN THE SYSTEM AND OBSERVED THAT THE BREATHING BAG HAD A HOLE". NO PATIENT INJURY, HARM, OR DESATURATION REPORTED. PATIENT CONDITION REPORTED AS "FINE".

Description of Event or Problem

IT WAS REPORTED "DURING THE VENTILATION TO THE PATIENT, THEY REALIZED THAT THERE WAS A LEAK IN THE SYSTEM AND OBSERVED THAT THE BREATHING BAG HAD A HOLE". NO PATIENT INJURY, HARM, OR DESATURATION REPORTED. PATIENT CONDITION REPORTED AS "FINE".

Additional Manufacturer Narrative

(B)(4). THE SAMPLE WAS RETURNED AND SENT TO THE MANUFACTURING SITE FOR INVESTIGATION. THE MANUFACTURING SITE REPORTS: "ONE (1) UNIT OF FG 5432 (BREATHING BAG, 2 LITER, LATEX FREE)" WAS RECEIVED FOR ANALYSIS. SIGNS OF USE ARE OBSERVED SINCE A DISINFECTION TAG IS PRESENT AND THE SAMPLE WAS NOT RECEIVED ON ITS ORIGINAL PACKAGE. DURING THE VISUAL INSPECTION TO RECEIVED SAMPLE IS NOT VISIBLE THE HOLE ISSUE. HOWEVER AS ADDITIONAL FUNCTIONAL TESTS ALTHOUGH THIS IS NOT PART OF THE NORMAL TESTING, A FUNCTIONAL TEST WAS PERFORMED TO THE SAMPLE. THE SAMPLE WAS ASSEMBLED INTO A TELEFLEX RESPIRATORY CIRCUIT AND A FUNCTIONAL LEAK TEST WAS PERFORMED ACCORDING TO CIRCUIT TELEFLEX PROCEDURES TESTING'S AND FUNCTIONAL RESULTS FAILED DUE A LEAK WAS OBSERVED. HOWEVER, CUSTOMER COMPLAINT CANNOT BE CONFIRMED AS MANUFACTURING ISSUE RELATED. A LEAK WAS OBSERVED ON P/N 10892-20 "BREATHING BAG ASSY, 2 LITER, LATEX FREE". HOWEVER IT CANNOT CONFIRM THAT SUCH DAMAGE WAS ORIGINATED DURING THE MANUFACTURE OF THE FG NOR CAUSED BY THE SUPPLIER OF THE COMPONENT P/N 10892-20 SINCE THIS IS SUPPLY BY AN EXTERNAL VENDOR. A NOTIFICATION WILL BE SENT TO THE VENDOR FOR FURTHER ANALYSIS. BASED ON PREVIOUS STATEMENTS IT IS NOT POSSIBLE TO ESTABLISH A CORRECTIVE ACTION."