MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-25 for DOVER * 145540 manufactured by Covidien.
[3071744]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2791971 |
| MDR Report Key | 2791971 |
| Date Received | 2012-09-25 |
| Date of Report | 2012-09-25 |
| Date of Event | 2012-07-12 |
| Report Date | 2012-09-25 |
| Date Reported to FDA | 2012-09-25 |
| Date Added to Maude | 2012-10-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOVER |
| Generic Name | KIT, ENEMA, (FOR CLEANING PURPOSE) |
| Product Code | FCE |
| Date Received | 2012-09-25 |
| Model Number | * |
| Catalog Number | 145540 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-25 |