FDA Adverse Event
Malfunction
Summary report: N
5.0FR URETHANE UMB CATH
MDR report key: 2130378
·
Received May 9, 2011
Report
- Report Number
- 1317749-2011-00138
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- March 14, 2011
- Report Date
- April 12, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 05/06/2011. 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 REPORTS THE PRODUCT BROKE AND WAS LEAKING JUST BELOW THE MOLDED STRAIN RELIEF ON THE EXTENSION. THE CUSTOMER REPORTS THE UVC WAS PLACED (B)(6) 2011 AND REMOVED (B)(6) 2011 AND A PERIPHERAL IV WAS INSERTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.0FR URETHANE UMB CATH | UVC | FOS | COVIDIEN | 8888160341 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |