MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-01 for POLYURETHANE NUTRISAFE 2 FEEDING TUBES 1364.042 manufactured by Vygon.
[106982544]
Patient Sequence No: 1, Text Type: N, H10
[106982545]
Upon measuring the nutrisafe2 tube (nasogastric tube, ngt) against the patient, i noticed that the number measured at an abnormally long length for this particular baby. That is when i noticed that the numbers on the tubing were backwards. At this point, i placed the faulty tubing into a bag. The ngt was never inserted into the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7475214 |
| MDR Report Key | 7475214 |
| Date Received | 2018-05-01 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-03-15 |
| Report Date | 2018-04-24 |
| Date Reported to FDA | 2018-04-24 |
| Date Reported to Mfgr | 2018-04-24 |
| Date Added to Maude | 2018-05-01 |
| 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 |
| 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 | POLYURETHANE NUTRISAFE 2 FEEDING TUBES |
| Generic Name | TUBE, FEEDING |
| Product Code | FPD |
| Date Received | 2018-05-01 |
| Model Number | 1364.042 |
| Catalog Number | 1364.042 |
| Lot Number | 150617FF |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-05-01 |