FDA Adverse Event
Malfunction
Summary report: N
FLEXIFLO ENTERAL FEEDING TUBE
MDR report key: 327318
·
Received April 9, 2001
Report
- Report Number
- 1528738-2001-00018
- Event Type
- Malfunction
- Date Received
- April 9, 2001
- Date of Event
- February 26, 2001
- Report Date
- February 27, 2001
- Manufacturer
- ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES
- Product Code
- BSS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A BOX OF NG TUBES (10 TUBES) WAS OPENED FOR DEMONSTRATION/TEACHING PURPOSES FOR STAFF NURSES. ONE OF THE TUBES WAS FOUND TO HAVE A STYLET THAT PROTRUDED THROUGH THE EYELET AT THE DISTAL END OF THE TUBE. THE TUBE WAS NOT USED ON A PT. ONE PT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 15777 | FLEXIFLO ENTERAL FEEDING TUBE | 78 BSS, TUBE, NASOGASTRIC | BSS | ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES | 55041 | 59-233-ZU-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |