InjuryFCD
E-Z-EM BARIUM SOLUTION PREFILLED ENEMA BAG
Received Aug 5, 1999
Report MW1016891 · MDR key 234970
Device
Generic name
Enema Bag Clamp
Manufacturer
E-z-em, Inc.Model number
NOT AVAILABLECatalog number
*
Lot number
*
Product problems
- Loose
Patient
71 YR
- 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. A LETTER WITH A COPY OF THE MEDWATCH FORM WILL BE SENT TO THE MFR. THE RADIOLOGY DEPT IS NOW USING TWO CLAMPS ON THE E-Z-EM ENEMA BAG, TO PREVENT ANY FUTURE OCCURRENCES.