FDA Adverse Event
Malfunction
Summary report: N
PALINDROME HSI 19/36 KIT VT CE
MDR report key: 3222158
·
Received July 2, 2013
Report
- Report Number
- 1317749-2013-00203
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Report Date
- June 6, 2013
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES A CRACK WAS NOTED IN THE EXTENSION OF THE ARTERIAL END OF THE CATHETER ONE WEEK AFTER INSERTION. A STATLOCK FIXATION DEVICE WAS USED AND THE CRACKING APPEARS TO BE AT THE AREA IN EXTENSION WHERE THE STATLOCK WAS IN PLACE. THE CATHETER WAS PULLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301766 | PALINDROME HSI 19/36 KIT VT CE | DIALYSIS CATHETER | MSD | COVIDIEN | 8888145057C | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |