FDA Adverse Event
Malfunction
Summary report: N
CURL CATH 62CM 2 CUFF
MDR report key: 4030197
·
Received July 15, 2014
Report
- Report Number
- 3009211636-2014-00017
- Event Type
- Malfunction
- Date Received
- July 15, 2014
- Date of Event
- July 2, 2014
- Report Date
- July 10, 2014
- Manufacturer
- COSTA RICA, COVIDIEN MANUFACTURING
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE CATHETER WAS IMPLANTED ON (B)(6) 2008. ON (B)(6) 2014 A CRACK WAS FOUND ON THE ADAPTER WHICH LEAD TO BLOOD LEAKAGE. THE CATHETER WAS PULLED AND REPLACED WITH A NEW ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 413401 | CURL CATH 62CM 2 CUFF | DIALYSIS CATHETER | MSD | COSTA RICA, COVIDIEN MANUFACTURING | 8811313010 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |