RUSCH NEOPRENE PECAN BAG 2L X 2

Additional Manufacturer Narrative

(B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE BLACK NEOPRENE INSERT WAS DETACHED FROM THE BAG. NO OTHER DEFECTS WERE DETECTED. SAMPLES OF CURRENT STOCK OF BAG PART NUMBER 212211202RM (NEOPRENE PECAN BAG 2L 22MM) LOT NO. 11686743 WHICH WERE AVAILABLE AT THE WAREHOUSE WERE INSPECTED WITH NO ISSUES FOUND. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. DURING THE VISUAL INSPECTION OF THE SAMPLE IT WAS OBSERVED THAT THE INSERT DETACHED FROM THE BAG. CORRECTIVE ACTIONS CANNOT BE DEFINED AND ESTABLISHED AT PRESENT TIME AS THE AFFECTED BAG IS A PURCHASED COMPONENT. A NOTIFICATION WILL BE SENT TO THE SUPPLIER TO DEFINE IF FURTHER ANALYSIS AND ACTIONS ARE REQUIRED. IN ADDITION, PERSONNEL FROM THE ASSEMBLY LINE HAVE BEEN NOTIFIED FOR AWARENESS. A CONCLUSION CODE COULD NOT BE FOUND AS THE COMPLAINT WAS CONFIRMED; HOWEVER, A ROOT CAUSE WAS NOT ESTABLISHED.

Description of Event or Problem

CUSTOMER COMPLAINT ALLEGES THAT THE "NECK PULLS AWAY FROM THE BAG". ALLEGED DEFECT WAS REPORTED AS DETECTED PRIOR TO USE/ DURING PRE-TESTING. NO REPORT OF HARM OR INJURY. PATIENT CONDITION REPORTED AS "FINE".

Additional Manufacturer Narrative

(B)(4). A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE DEVICE INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE DEVICE WAS NOT RETURNED AT THE TIME OF THIS REPORT. NO PHOTO OF THE ALLEGED DEFECT WAS PROVIDED. A DEVICE HISTORY RECORD REVIEW SHOWS THAT THE DEVICE WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. NO CONCLUSION CAN BE ESTABLISHED AT THIS TIME BASED ON THE LACK OF DEVICE OF SAMPLE. IT IS NECESSARY TO HAVE THE PHYSICAL SAMPLE IN ORDER TO PERFORM A PROPER INVESTIGATION. CUSTOMER COMPLAINT CANNOT BE CONFIRMED. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE, THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS.

Description of Event or Problem

CUSTOMER COMPLAINT ALLEGES THAT THE "NECK PULLS AWAY FROM THE BAG." ALLEGED DEFECT WAS REPORTED AS DETECTED PRIOR TO USE/ DURING PRE-TESTING. NO REPORT OF HARM OR INJURY. PATIENT CONDITION REPORTED AS "FINE."

Additional Manufacturer Narrative

QN#(B)(4). THE SAMPLE WAS RETURNED TO THE SUPPLIER FOR EVALUATION. THE RESULTS ARE AS FOLLOWS: THE SAMPLE WAS VISUALLY INSPECTED AND IT WAS OBSERVED THAT THE 22MM FERRULE WAS NOT ATTACHED TO THE PRODUCT. ONLY THE NECK BAND WAS REMAINED ATTACHED TO THE PRODUCT. NO TEARS OR CRACKS OBSERVED THROUGHOUT THE BAG. THE DIAMETER OF FERRULE RETURNED WAS MEASURED AT 2 POINTS AND FOUND TO BE WITHIN SPECIFICATION. THE FERRULE WAS THEN FIT TO THE RETURNED BREATHING BAG. TESTING WAS CONDUCTED AND THERE WAS NO DETACHMENT OF THE FERRULE FROM THE ASSEMBLED NECK OF THE BAG. THE MANUFACTURING PROCESS WAS ALSO REVIEWED AND NO ISSUES WERE IDENTIFIED. THERE HAS BEEN NO CHANGE IN THE DIPPING PROCESS, MATERIAL, MOLD, AND DESIGN FOR THIS PRODUCT. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THERE WERE NO ISSUES FOUND WITH THE RETURNED DEVICE. THE SAMPLE MET THE REQUIREMENT OF SECURITY OF ATTACHMENT OF FERRULE TO THE ASSEMBLED NECK WITH NO SIGNS OF DISCONNECTION IN ANY PART OF THE BREATHING BAG.

Description of Event or Problem

CUSTOMER COMPLAINT ALLEGES THAT THE "NECK PULLS AWAY FROM THE BAG". ALLEGED DEFECT WAS REPORTED AS DETECTED PRIOR TO USE/ DURING PRE-TESTING. NO REPORT OF HARM OR INJURY. PATIENT CONDITION REPORTED AS "FINE".