FDA Adverse Event
Malfunction
Summary report: N
PALINDROME HSI 28/45 KIT VT CE
MDR report key: 3190163
·
Received June 10, 2013
Report
- Report Number
- 1317749-2013-00178
- 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
(B)(4). 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)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE DOCTOR REPORTS THEY HAVE A PALINDROME CATHETER HAS MIGRATED OUT OF THE PT. THE CATHETER WAS IMPLANTED ON (B)(6) 2012 AND MIGRATED OUT ON (B)(6) 2013. SUTURES WERE IN PLACE FOR APPROXIMATELY 3 WEEKS. THIS EVENT OCCURRED AT THE PT'S HOME. THE PT IS ALSO RESPONSIBLE FOR HIS CLEANING AND DRESSING CHANGES. THE CATHETER WAS PULLED AND REPLACED ON (B)(6) 2013. THE PT HAS RECOVERED WITH NO FURTHER ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261879 | PALINDROME HSI 28/45 KIT VT CE | DIALYSIS CATHETER | MPB | COVIDIEN | 8888145049C | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |