InjuryFCD
SUPER XL DELIVERY SYSTEM
Received Sep 27, 1999 · Event occurred Oct 12, 1998
Report 2647856-1999-00040 · MDR key 242442
Device
Generic name
Empty Enema Kit For Air Contrast Studies
Manufacturer
E-z-em, Inc.Model number
NACatalog number
8925
Lot number
12498925
Product problems
- Loose
- Increase in Pressure
- Other (for use when an appropriate device code cannot be identified)
- Defective Component
Patient
*
- Internal Organ Perforation
Narrative
Description of Event or Problem
DURING A WATER SOLUBLE BARIUM ENEMA, THERE WAS A PERFORATION OF THE PT'S COLON. DURING A RETROSPECTIVE REVIEW OF THIS INCIDENT, FINALIZED 5/24/99, IT WAS DETERMINED THAT THE ROOT CAUSE OF THE PERFORATION WAS A CLAMP ON THE BARIUM ENEMA BAG THAT DID NOT HOLD IN THE CLOSED POSITION. THE PT'S CONDITION HAS BEEN STABLE SINCE THE INCIDENT.