MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for ENFIT 20 REF 8100-22-22F manufactured by Halyard.
[131376339]
We encountered a tube (enfit 20f) that was delivered with the bumper on the tube upside down. Unfortunately the placement team did not catch this and placed the tube causing stoma site harm to the pt. We reported this internally for our own reviews.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082361 |
| MDR Report Key | 8186268 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-12-11 |
| Date Added to Maude | 2018-12-20 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENFIT 20 |
| Generic Name | TUBE, FEEDING |
| Product Code | FPD |
| Date Received | 2018-12-19 |
| Model Number | REF 8100-22-22F |
| Lot Number | AA8176D17 |
| Device Expiration Date | 2018-12-25 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD |
| Manufacturer Address | ALPHARETTA GA 30005 US 30005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-12-19 |