N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 8384423
- MDR report key
- 8384423
- Report number
- 1018233-2019-01123
- Event key
- 0
- Event type
- 3
- Date received
- 2019-03-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- YONIC ANDERSON
- Address
- 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARD? PREVENT? ANTI-REFLUX FILTER | FILTERS FOR NG TUBE | C.R. BARD, INC. (COVINGTON) -1018233 | FEG | 0046000 | NGCU2173 | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-03-02 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE MARKINGS ON THE NG TUBE HAD RUBBED OFF. WITHOUT THE MARKINGS, THE NURSING STAFF COULD NOT DETERMINE WHERE THE NG TUBE WAS INSERTED, OR WHERE IT SHOULD BE LOCATED. ADDITIONALLY, IT WAS ALLEGED THAT RESIDUE REMAINED IN THE FILTERS AFTER USE.