DOVER
Received Mar 7, 2017 · Event occurred Feb 1, 2017
Report 9611712-2017-05001 · MDR key 6383441
Device
Product problems
- Device Operates Differently Than Expected
- Device Operates Differently Than Expected
Patient
Not reported
- No Patient Involvement
- No Information
- No Patient Involvement
- No Information
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 03/07/2017. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A URINARY CATHETER. THE CUSTOMER STATES THE BALLOON WOULD NOT DEFLATE.
Additional Manufacturer Narrative
NO SAMPLE WAS RECEIVED FOR THE EVALUATION. THE INVESTIGATION WAS BASED ON THE TREND ANALYSIS AND BATCH HISTORY REVIEW ONLY. FURTHER INVESTIGATION ON THE SAMPLE COULD NOT BE CONDUCTED. THE REPORTED CONDITION COULD NOT BE CONFIRMED. SINCE NO TREND EXISTS, AN ACTUAL ROOT CAUSE FOR THE REPORTED CONDITION CANNOT BE SPECIFICALLY IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS DONE. THE LOT WAS MANUFACTURED AS PER THE DEFINED DEVICE MASTER RECORD. ALL ACCEPTANCE CRITERIA WERE MET AND THIS BATCH WAS RELEASED MEETING ALL THE ACCEPTANCE CRITERIA. THE PROBABLE ROOT CAUSE FOR NON-DEFLATION USUALLY IS ASSOCIATED WITH UNEVEN RIB BALLOON THICKNESS DUE TO THE RIBBED OF THE FORMER BALLOON HAS WORN OUT. THE PRESSURE FROM THE WATER PRESSING ON THE LUMEN OF THE CATHETER COULD HAVE LED TO EXCESS WATER INSIDE THE BALLOON WHICH COULD NOT FLOW OUT THROUGH THE EYE. SINCE NO TREND EXISTS, AN ACTUAL ROOT CAUSE FOR THE REPORTED CONDITION CANNOT BE SPECIFICALLY IDENTIFIED; THEREFORE, CORRECTIVE ACTION WILL BE LIMITED TO THE MANUFACTURING AWARENESS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
THE CUSTOMER STATES THE BALLOON WOULD NOT DEFLATE.