FDA Adverse Event
Malfunction
Summary report: N
REPLACEMENT TUBE
MDR report key: 1213755
·
Received October 22, 2008
Report
- Report Number
- 1527460-2008-00873
- Event Type
- Malfunction
- Date Received
- October 22, 2008
- Date of Event
- September 26, 2008
- Report Date
- September 29, 2008
- Manufacturer
- ABBOTT NUTRITION
- Product Code
- KNT
- PMA / PMN Number
- K861323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.
Description of Event or Problem · 1
THE COMPLAINANT REPORTS A PORT LEAK. THE COMPLAINANT IS UNSURE OF THE LENGTH OF TIME THE TUBE HAS BEEN IN PLACE (POSSIBLY 3-4 MONTHS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLACEMENT TUBE | KNT, TUBES, GASTROINTESTINAL AND ACCESSORIES | KNT | ABBOTT NUTRITION | 51362 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |