FDA Adverse Event
Malfunction
Summary report: N
INDURA
MDR report key: 1032895
·
Received April 23, 2008
Report
- Report Number
- 6000030-2008-02166
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- March 12, 2008
- Report Date
- March 26, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE STYLET COULD NOT BE WITHDRAWN FROM THE CATHETER. DURING THE WITHDRAWAL PROCEDURE, THERE WAS DAMAGE TO THE CATHETER. THE CATHETER WAS CHANGED OUT IMMEDIATELY AND THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | RICE CREEK MANUFACTURING | 8709 | N131437006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |