MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for VYGON 1364.042 manufactured by Vygon.
[125472226]
Registered nurse was caring for this baby on the pm shift. The baby needed the nasogastric (ng) tube replaced. When she collected her supplies and measured for placement, she realized that the tubing numbers were reversed. This is a nutra safe, nasogastric tube, 4 french. Lot 081117ff, ref (b)(4), vygon value life. Device was not sequestered and is not available for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8018642 |
| MDR Report Key | 8018642 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-09-17 |
| Report Date | 2018-10-24 |
| Date Reported to FDA | 2018-10-24 |
| Date Reported to Mfgr | 2018-10-30 |
| Date Added to Maude | 2018-10-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | VYGON |
| Generic Name | TUBE, FEEDING |
| Product Code | FPD |
| Date Received | 2018-10-30 |
| Model Number | 1364.042 |
| Catalog Number | 1364.042 |
| Lot Number | 081117FF |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYGON |
| Manufacturer Address | 2750 MORRIS RD SUITE A200 LANSDALE PA 19446 US 19446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-30 |