FDA Adverse Event
Malfunction
Summary report: N
3.5FR P.U.R. UMBIL CATH X10
MDR report key: 2073039
·
Received April 21, 2011
Report
- Report Number
- 9611018-2011-00003
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- March 7, 2011
- Report Date
- March 22, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- NOT APPLICABLE
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 AN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTED THAT THE UVC WAS LEAKING BELOW THE MOLDED STRAIN RELIEF ON THE EXTENSION. THE UVC WAS INSERTED ON (B)(6) 2011, AND REMOVED ON (B)(6) 2011. THE CUSTOMER STATED THAT THE UVC WAS REPLACED WITH ANOTHER UVC AND THE PT STATUS IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5FR P.U.R. UMBIL CATH X10 | UVC | FOS | COVIDIEN | 8888160333 | 09L758E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |