FDA Adverse Event
Malfunction
Summary report: N
3.5FR URETHANE UMB CATH
MDR report key: 2233277
·
Received July 22, 2011
Report
- Report Number
- 1317749-2011-00221
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 25, 2011
- Report Date
- July 5, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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 AN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER STATES THAT AN UVC WAS PLACED ON (B)(6) 2011 AND SECURED WITH TEGADERM. ON (B)(6) 2011 THE UVC WAS NOTED TO BE LEAKING JUST BELOW THE MOLDED STRAIN RELIEF ON THE EXTENSIONS AND REMOVED. 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 URETHANE UMB CATH | FOS | COVIDIEN | 8888160333 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |