RUSCH LATEX BREATH BG 22MMBUSH
Received Jan 15, 2018 · Event occurred Dec 27, 2017
Report 8040412-2018-00018 · MDR key 7190842
Device
Product problems
- Hole In Material
- Leak/Splash
- Hole In Material
- Leak/Splash
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS COMPLAINT. USAGE OF THE DEVICE WAS NOT REPORTED. REPROCESSING HISTORY OF THE DEVICE HAS BEEN REQUESTED. TO DATE, THERE HAS BEEN NO RESPONSE FROM THE CUSTOMER. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.
Description of Event or Problem
CUSTOMER COMPLAINT ALLEGES THAT "A SMALL BURNT HOLE IN THE NECK OF THE BAG CAUSING A LEAK. THE BAG WAS REPLACED WITH A NEW ONE. NO PATIENT HARM."
Additional Manufacturer Narrative
(B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THERE IS A MELTED APPEARANCE ON THE SIDE PART OF THE BREATHING BAG. THE DEFECTIVE PART WAS STICKY AND CAUSED A HOLE TO THE PRODUCT. THE CUSTOMER REPORTS THAT THE DEFECT OCCURRED DURING USE. THUS, IT IS SUSPECTED THAT THE DETERIORATED AND MELTED APPEARANCE OCCURRED WHEN THE PRODUCT HAD BEEN DIRECTLY CONTACTED TO THE OBJECT WITH AN EXTREME HEATING ELEMENT WHICH MELTED THE PRODUCT. ALL PRODUCTS ARE SUBJECT TO A 100% VISUAL INSPECTION; THUS A DEFECT OF THIS TYPE WOULD BE DETECTED PRIOR TO THE PACKAGING PROCESS AT THE MANUFACTURING FACILITY. THE COMPLAINT OF HOLE IN THE PRODUCT WAS CONFIRMED; ALTHOUGH A TRUE ROOT CAUSE FOR THE ISSUE COULD NOT BE IDENTIFIED. A CONCLUSION CODE COULD NOT BE FOUND.
Description of Event or Problem
CUSTOMER COMPLAINT ALLEGES THAT "A SMALL BURNT HOLE IN THE NECK OF THE BAG CAUSING A LEAK. THE BAG WAS REPLACED WITH A NEW ONE. NO PATIENT HARM."