FDA Adverse Event
Summary report: N
DOVER
MDR report key: 2791971
·
Received September 25, 2012
Report
- Report Number
- 2791971
- Date Received
- September 25, 2012
- Date of Event
- July 12, 2012
- Report Date
- September 25, 2012
- Manufacturer
- COVIDIEN
- Product Code
- FCE
- Report Source
- User Facility report
- Reporter Location
- MD, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DOVER | KIT, ENEMA, (FOR CLEANING PURPOSE) | FCE | COVIDIEN | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |