MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-29 for NEOMED ENTERAL FEEDING TUBE FTM5.0P-EO manufactured by Neomed, Inc..
[118557427]
The hard plastic port at the top of the feeding tube has a small cut/tear. There is a small black arrow drawn onto the device pointing at the cut. This cut causes the device to leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7826147 |
| MDR Report Key | 7826147 |
| Date Received | 2018-08-29 |
| Date of Report | 2018-07-30 |
| Date of Event | 2018-07-22 |
| Report Date | 2018-07-30 |
| Date Reported to FDA | 2018-07-30 |
| Date Reported to Mfgr | 2018-08-29 |
| Date Added to Maude | 2018-08-29 |
| 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 | 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 | 3 |
| Brand Name | NEOMED ENTERAL FEEDING TUBE |
| Generic Name | TUBE, NASOGASTRIC |
| Product Code | BSS |
| Date Received | 2018-08-29 |
| Model Number | FTM5.0P-EO |
| Catalog Number | FTM5.0P-EO |
| Lot Number | 20180620 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOMED, INC. |
| Manufacturer Address | 100 LONDONDERRY CT SUITE 112 WOODSTOCK GA 30188 US 30188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |