FDA Adverse Event
Malfunction
Summary report: N
5FR DUAL-LUMEN UVC CATH
MDR report key: 1243101
·
Received November 21, 2008
Report
- Report Number
- 1317749-2008-00190
- Event Type
- Malfunction
- Date Received
- November 21, 2008
- Date of Event
- November 2, 2008
- Report Date
- November 7, 2008
- Manufacturer
- COVIDIEN
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN IN 2008 THAT A CUSTOMER HAD AN ISSUE WITH A UVC. THE CUSTOMER REPORTS THAT THE CATHETER HAD DROPLETS OF FLUID NOTED AT THE JUNCTION OF THE PRIMARY AND SECONDARY SITE. CUSTOMER REPORTS THE LEAK APPEARED TO BE IN THE PRIMARY INFUSION LINE. CATHETER HAD BEEN PLACED FOR 4 DAYS. CATHETER WAS REMOVED WHEN LEAK WAS FOUND. PERIPHERAL IV WAS PLACED INSTEAD. PATIENT DISCHARGED 1 DAY LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5FR DUAL-LUMEN UVC CATH | UVC | FOS | COVIDIEN | 8888160556 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |