MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-22 for MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS 8100-22 manufactured by Halyard / Avanos Medical Inc..
[118146760]
Notified that pt's tube required replacement today (b)(6) 2018 by ir with a 22 fr g tube secondary #1. The cap was not closing #2. There were two pin holes in the distal end of the tube near the connector placement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079330 |
| MDR Report Key | 7809318 |
| Date Received | 2018-08-22 |
| Date of Report | 2018-08-20 |
| Date of Event | 2018-08-09 |
| Date Added to Maude | 2018-08-23 |
| 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 | 0 |
| 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 | MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS |
| Generic Name | ENFIT G-TUBE |
| Product Code | FPD |
| Date Received | 2018-08-22 |
| Returned To Mfg | 2018-08-10 |
| Model Number | 8100-22 |
| Lot Number | AA8148D19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD / AVANOS MEDICAL INC. |
| Manufacturer Address | ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-22 |