FDA Adverse Event
Malfunction
Summary report: N
3.5FR URETHANE UMB CATH
MDR report key: 3170473
·
Received May 24, 2013
Report
- Report Number
- 1317749-2013-00162
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- April 21, 2013
- Report Date
- April 25, 2013
- 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS A HOLE/CRACK IN LINE WHERE THE CATHETER ATTACHES TO THE HUB PORTION APPROXIMATELY 2 HOURS AFTER FLUIDS/TUBING WERE CHANGED. THE CUSTOMER FURTHER REPORTS THE UVC WAS NOT DIFFICULT TO HANDLE DURING INSERTION AND THE UVC WAS REMOVED ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232239 | 3.5FR URETHANE UMB CATH | UMBILICAL VESSEL CATHETER | FOS | COVIDIEN | 8888160333 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |