MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-20 for NUTRISAFE 2Y 368.42 manufactured by Vygon Corporation.
[45596964]
Patient Sequence No: 1, Text Type: N, H10
[45596965]
We are experiencing ongoing issues with the faulty nutrisafe 2 y-connector with oral port, which easily breaks at the connection with the oral port.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5669312 |
| MDR Report Key | 5669312 |
| Date Received | 2016-05-20 |
| Date of Report | 2016-05-17 |
| Date of Event | 2016-02-28 |
| Report Date | 2016-05-17 |
| Date Reported to FDA | 2016-05-17 |
| Date Reported to Mfgr | 2016-05-17 |
| Date Added to Maude | 2016-05-20 |
| 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 | 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 | 3 |
| Brand Name | NUTRISAFE 2Y |
| Generic Name | ENTERAL SPECIFIC TRANSITION CONNECTOR |
| Product Code | PIO |
| Date Received | 2016-05-20 |
| Catalog Number | 368.42 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYGON CORPORATION |
| Manufacturer Address | 2750 MORRIS RD SUITE A200 LANSDALE, PA 19446 US 19446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-20 |