FDA Adverse Event
Malfunction
Summary report: N
PALINDROME 55/72 KIT W/SLOT
MDR report key: 4121796
·
Received July 28, 2014
Report
- Report Number
- 1317749-2014-00307
- Event Type
- Malfunction
- Date Received
- July 28, 2014
- Date of Event
- July 22, 2014
- Report Date
- July 24, 2014
- Manufacturer
- COSTA RICA COVIDIEN MANUFACTURING
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT PHYSICIAN FOUND LEAKAGE IN Y-JUNCTION. THE CATHETER WAS PLACED ON (B)(6) 2012, THE CATHETER WAS PULLED AND REPLACED ON (B)(6) 2014. PERMANENCE TIME OF THE CATHETER IN THE PT 1 YEAR WITH 8 MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439892 | PALINDROME 55/72 KIT W/SLOT | DIALYSIS CATHETER | MSD | COSTA RICA COVIDIEN MANUFACTURING | 8888145018 | 119867 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |