MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-18 for VYGON NUTRISAFE2 368.02 manufactured by Vygon.
[133846869]
Nasal gastric tube adapter for liquid nutrition device separated where the small flexible part fell off into the crib area. Based on the age of the pt, the pt may have experienced a choking hazard. Nicu pt requiring feeding via ngt. Potential choking hazard. Broken device found in crib; discovered by nursing staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083254 |
| MDR Report Key | 8266878 |
| Date Received | 2019-01-18 |
| Date of Report | 2019-01-09 |
| Date of Event | 2019-01-08 |
| Date Added to Maude | 2019-01-22 |
| 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 |
| 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 | VYGON NUTRISAFE2 |
| Generic Name | TUBE, FEEDING |
| Product Code | FPD |
| Date Received | 2019-01-18 |
| Model Number | NUTRISAFE2 |
| Catalog Number | 368.02 |
| Lot Number | 040917FF |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYGON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-18 |