FDA Adverse Event
Malfunction
Summary report: N
PALINDROME EMERALD 23/40 KIT
MDR report key: 2843558
·
Received October 24, 2012
Report
- Report Number
- 1317749-2012-00264
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Date of Event
- August 3, 2012
- Report Date
- October 22, 2012
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2012. 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 THAT THE CATHETER WAS CRACKED. THE NURSING TEAM NOTICED A BLOOD LEAK ON (B)(6) 2012. THE CATHETER WAS PULLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALINDROME EMERALD 23/40 KIT | DIALYSIS CATHETER | MSD | COVIDIEN | 8888145044C | 128705X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |