FDA Adverse Event
Malfunction
Summary report: N
3. 5FR URETHANE UMB CATH
MDR report key: 2023135
·
Received February 15, 2011
Report
- Report Number
- 1317749-2011-00040
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Report Date
- January 26, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 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 UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT THE UVC IS CRACKING AND LEAKING AT THE HUB. THE CUSTOMER STATED THAT THE UVC WAS IN PLACE FOR LESS THAN 14 DAYS. THE CUSTOMER STATED THAT THE LINE WAS NOT REPLACED AND THE PATIENT STATUS IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3. 5FR URETHANE UMB CATH | UMBILICAL VESSEL CATHETER | FOS | COVIDIEN | 8888160333 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |