FDA Adverse Event
Malfunction
Summary report: N
3.5FR P.U.R. UMBIL CATH X10
MDR report key: 2030783
·
Received March 22, 2011
Report
- Report Number
- 9611018-2011-00001
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- February 22, 2011
- Report Date
- March 8, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 WAS LEAKING BELOW THE HUB WHERE THE CATHETER IS JOINED. THE UVC WAS PLACED ON (B)(6) 2011 AND REMOVED ON (B)(6) 2011. THE CUSTOMER STATED THAT THE UVC WAS NOT REPLACED 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 | UMBILICAL VESSEL CATHETER | FOS | COVIDIEN | 8888160333 | 06B690E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |