MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-15 for ENFIT G TUBE 8100-18 18F manufactured by Halyard/avanos Medical, Inc.
[133718684]
Writer notified by nursing staff of peg tube malfunction. Writer observed internal piece to one of the enfit ports to be missing ,therefore not allowing the top of the port to close securely. Nursing instructed to cleanse malfunctioning port and tape top down. Alternate port is viable and will be used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083152 |
| MDR Report Key | 8253296 |
| Date Received | 2019-01-15 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-12-31 |
| Date Added to Maude | 2019-01-16 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | ENFIT G TUBE |
| Generic Name | TUBE, FEEDING |
| Product Code | FPD |
| Date Received | 2019-01-15 |
| Model Number | 8100-18 18F |
| Lot Number | AA8043D20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD/AVANOS MEDICAL, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-15 |