FDA Adverse Event
Malfunction
Summary report: N
3.5FR URETHANE UMB CATH
MDR report key: 2231072
·
Received July 20, 2011
Report
- Report Number
- 1317749-2011-00200
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Report Date
- June 22, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
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 REPORTS THE UVC WAS PLACED AND FOUND TO BE CRACKED/LEAKING JUST BELOW THE MOLDED STRAIN RELIEF ON THE EXTENSION. THE UVC WAS REMOVED THE SAME DAY AND REPLACED WITH ANOTHER UVC. THE CUSTOMER REPORTS THE PT STATUS IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5FR URETHANE UMB CATH | UVC | FOS | COVIDIEN | 8888160333 | 032362 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |