MalfunctionFCE
SUPER XL ENEMA SYSTEM
Received Jul 20, 2017 · Event occurred Jun 29, 2017
Report MW5071126 · MDR key 6732264
Device
Product problems
- Leak/Splash
Patient
NA
- No Information
- No Information
Narrative
Description of Event or Problem
REPORTED TO RISK THAT RADIOLOGY WAS PERFORMING A TEST AND USING THE BARIUM ENEMA BAG ON A PT WHEN THE BALLOON MECHANISM LEAKED. THIS REQUIRED THE ENEMA BAG SYSTEM TO HAVE TO BE REPLACED AND REPEATED INSTILLATION OF BARIUM. THIS IS NOT THE FIRST REPORT TO THE COMPANY OF THIS TYPE OF SITUATION WITH THE SUPER XL ENEMA SYSTEM. A MED-WATCH WAS COMPLETED BACK IN (B)(6) WITH THE SAME SITUATION BUT A DIFFERENT LOT NUMBER IS INVOLVED. THIS DEVICE WAS NOT SAVED BUT THERE WAS ONE MORE ENEMA BAG SYSTEM TO THIS LOT NUMBER IN STOCK AND WAS PULLED FROM STOCK AND SEQUESTERED BY RISK.