FDA Adverse Event
Malfunction
Summary report: N
C-GON / NUTRISAFE 5 ML FEEDING SYRINGE
MDR report key: 6636315
·
Received June 9, 2017
Report
- Report Number
- MW5070354
- Event Type
- Malfunction
- Date Received
- June 9, 2017
- Date of Event
- June 7, 2017
- Report Date
- June 9, 2017
- Manufacturer
- VYGON
- Product Code
- FPD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
WHILE DRAWING UP STERILE WATER FOR A FEEDING, THE NURSE NOTICED A SHARD OF PURPLE PLASTIC IN THE BARREL OF THE SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410376 | C-GON / NUTRISAFE 5 ML FEEDING SYRINGE | TUBE, FEEDING | FPD | VYGON | H80117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |