MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-01-24 for NUTRISAFE FEEDING TUBE 1362.062 manufactured by Vygon.
[135453173]
The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation. The results of this investigation are pending and will be communicated to fda within 30 days of its conclusion via follow up mdr.
Patient Sequence No: 1, Text Type: N, H10
[135453174]
The patient is a (b)(6) baby. The nurse noticed a partial obstruction when she was going to administer the feeding solution. The solution flowed slowly with difficulties. This malfunction necessitated the withdrawal and the feeding tube replacement. No patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245270-2019-00005 |
| MDR Report Key | 8274865 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-01-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2018-11-07 |
| Date Mfgr Received | 2018-12-26 |
| Date Added to Maude | 2019-01-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 FEEDING TUBE |
| Generic Name | NUTRISAFE FEEDING TUBE |
| Product Code | FPD |
| Date Received | 2019-01-24 |
| Model Number | 1362.062 |
| Catalog Number | 1362.062 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-24 |