FDA Adverse Event
Injury
Summary report: N
NEOMED CATHETER - ENTERAL FEEDING
MDR report key: 12835689
·
Received November 17, 2021
Report
- Report Number
- MW5105435
- Event Type
- Injury
- Date Received
- November 17, 2021
- Date of Event
- September 23, 2021
- Report Date
- November 16, 2021
- Manufacturer
- NEOMED, INC. / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
- Product Code
- FPD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
INFANT HAD 5.0 FR 60CM PVC ENTERAL FEEDING TUBE IN PLACE. THIS RN NOTED UPON INSPECTION THAT ADAPTER AT THE END OF THE FEEDING TUBE HAD FALLEN OFF. FEEDING TUBE REMOVED AND REPLACED WITH NEW ENTERAL FEEDING TUBE. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1724549 | NEOMED CATHETER - ENTERAL FEEDING | TUBE, FEEDING | FPD | NEOMED, INC. / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) | 20200608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 MO | Prefer Not To Disclose | Required Intervention |