FDA Adverse Event
Malfunction
Summary report: N
TUBE, GASTROINTESTINAL (AND ACCESS)
MDR report key: 1022311
·
Received March 31, 2008
Report
- Report Number
- 2523003-2008-00021
- Event Type
- Malfunction
- Date Received
- March 31, 2008
- Date of Event
- February 29, 2008
- Report Date
- March 6, 2008
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- KNT
- PMA / PMN Number
- K915841
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR HAD RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.
Description of Event or Problem · 1
A BREAK IN THE RETENTION DOME DURING TRACTION REMOVAL. THE BROKEN RETENTION DOME REMAINED IN THE STOMACH. THE INDWELLING PERIOD WAS 287 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TUBE, GASTROINTESTINAL (AND ACCESS) | KNT | C.R. BARD, INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |