FDA Adverse Event
Malfunction
Summary report: N
USE
MDR report key: 72934
·
Received February 24, 1997
Report
- Report Number
- 72934
- Event Type
- Malfunction
- Date Received
- February 24, 1997
- Date of Event
- February 6, 1997
- Report Date
- February 18, 1997
- Manufacturer
- USE-GASTROTRAC
- Product Code
- KGC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ON 2/6/97, JEJUNAL FEEDING TUBE WAS PLACED THROUGH A PT G-TUBE, WITHOUT EVENT. HOWEVER ON 2/14/97, PHYSICIAN REPORTED THAT THE J-TUBE SEPARATED FROM THE ADAPTER AND MIGRATED TO THE SM BOWEL. 2/14/94 X-RAY REVEALED J-TUBE IN STOMACH; REMOVED VIA ENDOSCOPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | USE Implant | FEEDING TUBE | KGC | USE-GASTROTRAC | JEJUNAL TUBE | 9402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |