MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-01 for NEOMED 5.0 FRENCH 60CM PUR FTM5.0P-EO manufactured by Neomed Incorporated.
[122624811]
This premature baby had a 5fr. Neomed feeding tube placed nasally. The cap pops open after feeds and loss of feeding is noted. The feeding tube cap was taped closed as the cap would not stay shut. In addition, when feeding tube was connected to enteral feeding tubing (extension set), the extension set became lodged in the feeding tube and had to be dislodged using a kelly clamp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080272 |
| MDR Report Key | 7926252 |
| Date Received | 2018-10-01 |
| Date of Report | 2018-09-18 |
| Date of Event | 2018-05-08 |
| Date Added to Maude | 2018-10-02 |
| 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 | RISK MANAGER |
| 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 | NEOMED 5.0 FRENCH 60CM PUR |
| Generic Name | FEEDING TUBE |
| Product Code | FPD |
| Date Received | 2018-10-01 |
| Model Number | FTM5.0P-EO |
| Catalog Number | FTM5.0P-EO |
| Lot Number | 2017 1227 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOMED INCORPORATED |
| Manufacturer Address | 100 LONDONDERRY CT, STE 112 WOOD STOCK GA 30188 US 30188 |
| Brand Name | NEOMED 5.0 FRENCH 60CM PUR |
| Generic Name | TUBE GASTROINTESTINAL (AND ACCESSORIES) |
| Product Code | KNT |
| Date Received | 2018-10-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | NEOMED INCORPORATED |
| Manufacturer Address | 100 LONDONDERRY CT STE 112 WOOD STOCK GA 30188 US 30188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-01 |