MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-15 for BAG, ENEMA FLIP TOP DRY DYND70102 manufactured by Medline.
[1164062]
Patient told risk management gave himself the enema while on the floor and he left the cap on, when he pulled it out, the cap was not on and he told the nurse. Patient was provided the supplies and instructions. Additional info obtained from the site:cap was left inside the patient and cap extractedin medical procedure unit (mpu). We had a similar report in january 4th of 2009. All of enema kits from medline packaging lacks instructions to remove the (dark blue) end cap prior to insertion. We have switched our products from medline ( dynd70102) to medichoice (enbg1500), the product from medichoice has clearer directions. ====================== manufacturer response for bag, enema flip top dry, bag, enema flip top dry======================working on adding instructions to remove the (dark blue) end cap prior to insertion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1398271 |
| MDR Report Key | 1398271 |
| Date Received | 2009-05-15 |
| Date of Report | 2009-05-15 |
| Date of Event | 2009-04-01 |
| Report Date | 2009-05-15 |
| Date Reported to FDA | 2009-05-15 |
| Date Added to Maude | 2009-06-05 |
| 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 | 0 |
| 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 | BAG, ENEMA FLIP TOP DRY |
| Generic Name | CATHETER, RETENTION, BARIUM ENEMA WITH BAG |
| Product Code | FGD |
| Date Received | 2009-05-15 |
| Model Number | NA |
| Catalog Number | DYND70102 |
| Lot Number | NA |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-15 |