FDA Adverse Event
Malfunction
Summary report: N
5.0FR URETHANE UMB CATH
MDR report key: 1162297
·
Received September 5, 2008
Report
- Report Number
- 1317749-2008-00146
- Event Type
- Malfunction
- Date Received
- September 5, 2008
- Date of Event
- August 8, 2008
- Report Date
- August 12, 2008
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 09/03/2008. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL, THAT A CUSTOMER HAD A PROBLEM WITH A UMBILICAL CATHETER. THE CUSTOMER REPORTS UVC CATHETER WAS PLACED AND ON THE MORNING OF 2008, IT WAS DISCOVERED THAT THE CATHETER BROKE BENEATH THE HUB CAUSING IV SOLUTION TO LEAK INTO THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.0FR URETHANE UMB CATH | UMBILICAL CATHETER | FOS | TYCO HEALTHCARE/KENDALL | 8888160341 | 183948 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |