MalfunctionFGD
SUPER XL ENEMA SYSTEM
Received Jun 30, 2017 · Event occurred May 31, 2017
Report 6680242 · MDR key 6680242
Device
Generic name
Barium Enema Catheter
Manufacturer
E-z-em, Inc. (bracco Diagnostics)Model number
901203Catalog number
901203
Lot number
60051579
Product problems
- Deflation Problem
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
THE FOLLOWING ELEMENTS HAVE BLANK DATA
Description of Event or Problem
THE BALLOON ON THE ENEMA TIPS ARE DEFLATING. THIS HAS HAPPENED ON AT LEAST 4 RECENT PATIENTS. WHILE PERFORMING AN ENEMA ON MULTIPLE PATIENTS, THE BALLOON THAT KEEPS THE TIP IN PLACE SLOWLY DEFLATES. DURING ONE EXAM WE HAD TO REINSERT THE TIP SO THE EXAM COULD BE COMPLETED. SISTER HOSPITAL INDICATED THAT THEY WERE HAVING SIMILAR ISSUES WITH THIS PRODUCT.