FDA Adverse Event
Malfunction
Summary report: N
3.5FR URETHANE UMB CATH
MDR report key: 2130382
·
Received May 9, 2011
Report
- Report Number
- 1317749-2011-00152
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- January 19, 2011
- Report Date
- April 12, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 05/06/2011. 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH AN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTED THAT A LEAK WAS NOTICED BELOW THE HUB WHERE THE CATHETER IS JOINED. THE UVC WAS INSERTED ON (B)(6) 2011 AND WAS REMOVED ON (B)(6) 2011. THE UVC WAS NOT REPLACED AFTER REMOVAL. THE CUSTOMER REPORTS THAT 2-3 WEEKS AFTER PLACEMENT THE PT DIED; HOWEVER, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE DATE OF PT DEATH. THE CUSTOMER FURTHER STATED THAT THERE IS NO CORRELATION BETWEEN THE UVC AND THE PT'S DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5FR URETHANE UMB CATH | UVC | FOS | COVIDIEN | 8888160333 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |