FDA Adverse Event
Malfunction
Summary report: N
PALINDROME EMERALD 23/40KIT VT
MDR report key: 2861155
·
Received November 2, 2012
Report
- Report Number
- 1317749-2012-00273
- Event Type
- Malfunction
- Date Received
- November 2, 2012
- Date of Event
- June 27, 2012
- Report Date
- October 29, 2012
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
- Product Code
- NYU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS THE CATHETER WAS INSERTED ON (B)(6) 2012. THE CATHETER CRACKED ABOVE THE HUB ON (B)(6) 2012 AND PULLED AND REPLACED ON THAT SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALINDROME EMERALD 23/40KIT VT | DIALYSIS CATHETER | NYU | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL | 8888145044 | 135002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |