MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-18 for NUTRISAFE 2 368.02 manufactured by Vygon.
[139112686]
This malfunction was also sent to fda via medwatch report number mw5083147. The results of this investigation are still pending,and will be reported to fda withing thirty days of its conclusion via follow-up mdr.
Patient Sequence No: 1, Text Type: N, H10
[139112687]
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 patient, the patient may have experienced a choking hazard. Nicu patient requiring deeding via ngt. Broken device found in crib.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245270-2019-00012 |
| MDR Report Key | 8348528 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-18 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-01-08 |
| Date Mfgr Received | 2019-02-08 |
| Date Added to Maude | 2019-02-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | FREDA LACROIX |
| Manufacturer Street | 2750 MORRIS ROAD |
| Manufacturer City | LANSDALE PA 19446 |
| Manufacturer Country | US |
| Manufacturer Postal | 19446 |
| Manufacturer Phone | 8004735414 |
| Manufacturer G1 | VYGON |
| Manufacturer Street | 5 RUE ADELINE |
| Manufacturer City | ECOUEN, 95440 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 95440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUTRISAFE 2 |
| Generic Name | FEEDING TUBE |
| Product Code | FPD |
| Date Received | 2019-02-18 |
| Model Number | 368.02 |
| Lot Number | 040917FF? |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYGON |
| Manufacturer Address | 5 RUE ADELINE ECOUEN, 95440 FR 95440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-18 |