FDA Adverse Event
Malfunction
Summary report: N
3.5FR URETHANE UMB CATH
MDR report key: 1945294
·
Received December 21, 2010
Report
- Report Number
- 1317749-2010-00336
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Date of Event
- November 30, 2010
- Report Date
- December 1, 2010
- Manufacturer
- COVIDIEN
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2010. AN INVESTIGATION IS UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010, THAT A CUSTOMER HAD AN ISSUE WITH AN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTED THAT THE UVC WAS PLACED WITH NO DIFFICULTY, PLACEMENT OF THE UVC WAS VERIFIED WITH X-RAY. WHEN THE UVC WAS ATTACHED TO THE FLUID LINE, IT WAS NOTICED THAT FLUIDS WERE LEAKING FROM THE HUB AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5FR URETHANE UMB CATH | UVC/UAC | FOS | COVIDIEN | 8888160333 | 026783 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |