FDA Adverse Event
Malfunction
Summary report: N
PALINDROME HSI 28/45 KIT VT CE
MDR report key: 3190208
·
Received June 10, 2013
Report
- Report Number
- 1317749-2013-00175
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Report Date
- May 17, 2013
- Manufacturer
- COVIDIEN
- Product Code
- MPB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE DOCTOR REPORTS THEY HAVE A PALINDROME CATHETER HAS MIGRATED OUT OF THE PATIENT. THE CATHETER WAS IMPLANTED ON (B)(6) 2012 AND MIGRATED OUT ON (B)(6) 2012. SUTURES WERE IN PLACE FOR APPROXIMATELY 3 WEEKS. THIS EVENT OCCURRED AT THE PATIENT'S HOME. THE CATHETER WAS PULLED AND REPLACED ON (B)(6) 2012. THE PATIENT HAS RECOVERED WITH NO FURTHER ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261882 | PALINDROME HSI 28/45 KIT VT CE | DIALYSIS CATHETER | MPB | COVIDIEN | 8888145049C | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |