ENEMA BAG
Received Nov 7, 2012 · Event occurred Jul 12, 2012
Report 9612030-2012-00054 · MDR key 2833126
Product problems
- Improper or Incorrect Procedure or Method
Patient
UNK
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH AN ENEMA BAG. THE CUSTOMER REPORTS; THE PT REPORTED RECTAL FULLNESS AND BLOOD ON TOILET PAPER. AN ANEMA HAD BEEN ADMINISTERED EARLIER IN THE DAY. UPON EXAMINATION A BLUE, APPROX 5-INCH PLASTIC CAP FROM THE ENEMA BAG TUBING, WAS FOUND IN THE PT'S RECTUM. THE RN DID NOT REALIZE THE CAP SHOULD BE REMOVED. THERE IS NO LABELING ON THE CAP NOT TO INSERT INTO PT. THERE IS ALSO NOTHING IN THE PRODUCT LITERATURE TO ENSURE THE CAP IS REMOVED AND DISPOSED OF PRIOR TO INSERTION INTO PT.
Additional Manufacturer Narrative
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED. COVIDIEN PRODUCT MONITORING CONTACTED THE CUSTOMER ON (B)(4) 2012 TO REQUEST ADD'L INFO. ON (B)(4) 2012, (B)(6) FROM THE RISK MANAGEMENT OFFICE COMMUNICATED THAT PER HOSPITAL'S POLICY, INFO REGARDING PT'S MEDICAL PROCEDURES IS CONSIDERED CONFIDENTIAL AND NO ADD'L INFO COULD BE PROVIDED. AMY FURTHER STATED THAT PT'S CONDITION IS STABLE.