FDA Adverse Event
Malfunction
Summary report: N
3.5 FR P.U.R. UMBIL CATH X10
MDR report key: 3944305
·
Received May 8, 2014
Report
- Report Number
- 1317749-2014-00201
- Event Type
- Malfunction
- Date Received
- May 8, 2014
- Date of Event
- April 9, 2014
- Report Date
- April 11, 2014
- Manufacturer
- COVIDIEN
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. SEVER ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT THE CATHETER WAS PLACED AT END MORNING, AT 8 PM A LEAK WAS NOTICED AT THE JUNCTION OF THE CATHETER AND THE ADAPTER. THE DEVICE WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278020 | 3.5 FR P.U.R. UMBIL CATH X10 | UMBILICAL VESSEL CATHETER | FOS | COVIDIEN | 8888160333 | 305303X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |