SUPER XL ENEMA SYSTEM
Received Apr 5, 2017 · Event occurred Mar 2, 2017
Report MW5068973 · MDR key 6471473
Device
Generic name
Enema Kit
Manufacturer
E-z-em Inc.Model number
901203Catalog number
901203
Lot number
60015821
Product problems
- Component Falling
- Leak/Splash
Patient
NA
- No Code Available
- No Code Available
Narrative
Description of Event or Problem
REPORTED TO PATIENT SAFETY AND THEN TO RISK THAT RADIOLOGY RECEIVED A BATCH OF BAD ENEMA KITS. THEY HAD GONE THROUGH 4 KITS IN THE BATCH AND EACH ONE USED WOULD LEAK FROM THE BALLOON SEAL. WHEN THE BALLOON DEFLATES, IT WOULD CAUSE THE RETENTION BALLOON TO ALLOW THE CATHETER TIP TO FALL OUT OF THE RECTUM. THIS WOULD CAUSE THE RADIOLOGY TECHS TO HAVE TO INSERT THE ENEMA TIP AND REINFLATE THE BALLOON IN ORDER TO COMPLETE THEIR TEST. THE REMAINDER OF THIS LOT NUMBER WAS PULLED FROM THE SHELF AND SEQUESTERED BY RISK MANAGEMENT. IF THE MANUFACTURE WOULD LIKE THE REMAINDER OF THE KITS FROM THIS LOT THEY CAN SEND THE COMPANY REPRESENTATIVE TO COME OBTAIN THE ITEMS FOR THEIR INVESTIGATION.