RUSCH NEOPRENE PECAN BAG 2L X 2
Received Jan 26, 2017 · Event occurred Jan 13, 2017
Report 3004365956-2017-00049 · MDR key 6280354
Device
Product problems
- Disconnection
- Disconnection
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
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 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".