FDA Adverse Event
Malfunction
Summary report: N
ENFIT NASOGASTRIC TUBE
MDR report key: 18302646
·
Received December 8, 2023
Report
- Report Number
- MW5149068
- Event Type
- Malfunction
- Date Received
- December 8, 2023
- Date of Event
- November 22, 2023
- Report Date
- December 5, 2023
- Manufacturer
- KENTEC MEDICAL, INC.
- Product Code
- FPD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
NG(NASOGASTRIC) TUBE TAB TO OPEN AND CLOSE CAP BROKEN OFF. HAD TO PLACE A NEW ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1830873 | ENFIT NASOGASTRIC TUBE | TUBE, FEEDING | FPD | KENTEC MEDICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Male |