FDA Adverse Event
Malfunction
Summary report: N
3.5FR URETHANE UMB CATH
MDR report key: 2123633
·
Received June 10, 2011
Report
- Report Number
- 1317749-2011-00177
- Event Type
- Malfunction
- Date Received
- June 10, 2011
- Date of Event
- May 30, 2011
- Report Date
- May 31, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 06/08/2011. 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 A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT A LEAK/CRACK WAS NOTICED AT THE HUB. THE CATHETER WAS PLACED ON (B)(6) 2011 AND WAS REMOVED ON THE SAME DAY. THE CUSTOMER STATED THAT THE CATHETER WAS REPLACED WITH ANOTHER SINGLE LUMEN UVC AND THE PT STATUS IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5FR URETHANE UMB CATH | UMBILICAL VESSEL CATHETER | FOS | COVIDIEN | 8888160333 | 100023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |