FDA Adverse Event
Malfunction
Summary report: N
PALINDROME RT 15FR 19CM KIT
MDR report key: 2050451
·
Received April 5, 2011
Report
- Report Number
- 1317749-2011-00118
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Report Date
- March 25, 2011
- Manufacturer
- COVIDIEN
- Product Code
- MPB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 04/05/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON 03/25/2011 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THE CATHETER LEAKED, RIGHT BELOW THE Y EXTENSIONS. THE CATHETER HAD TO BE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALINDROME RT 15FR 19CM KIT | HEMODIALYSIS CATHETER | MPB | COVIDIEN | 8888541019 | 028165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |