DOVER
Received Sep 25, 2012 · Event occurred Jul 12, 2012
Report 2791971 · MDR key 2791971
Device
Product problems
- Detachment Of Device Component
Patient
19 YR
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
THE PATIENT REPORTED RECTAL FULLNESS AND BLOOD ON TOILET PAPER. AN ENEMA HAD BEEN ADMINISTERED EARLIER IN THE DAY. UPON EXAMINATION A BLUE, APPROXIMATELY 5-INCH PLASTIC CAP FROM THE ENEMA BAG TUBING, WAS FOUND IN THE PATIENT'S RECTUM. THE RN DID NOT REALIZE THE CAP SHOULD BE REMOVED. THE IS NO LABELING ON THE CAP NOT TO INSERT INTO PATIENT. THERE IS ALSO NOTHING IN THE PRODUCT LITERATURE TO ENSURE THE CAP IS REMOVED AND DISPOSED OF PRIOR TO INSERTION INTO THE PATIENT. THIS HAS HAPPENED ON 3 DIFFERENT UNITS WITH 3 DIFFERENT PATIENTS.