FDA Adverse Event
Malfunction
Summary report: N
EPICUTANEO CAVA CATHETER
MDR report key: 4047533
·
Received April 7, 2014
Report
- Report Number
- 2245270-2014-00032
- Event Type
- Malfunction
- Date Received
- April 7, 2014
- Date of Event
- November 13, 2013
- Report Date
- April 3, 2014
- Manufacturer
- VYGON CORP.
- Product Code
- LJS
- PMA / PMN Number
- K897168
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH THIS MALFUNCTION OCCURRED IN 2013, IT IS BEING REPORTED TO FDA AS A RESULT OF A (B)(4) AUDIT OBSERVATION REGARDING MDR REPORTING GIVEN TO VYGON (B)(4) ON (B)(4) 2014. THIS COMPLAINT IS NOT CONFIRMED. HAVING EXAMINED THE SAMPLE RETURNED, WE FOUND AN EPICUTANEO-CAVA-CATHETER, WHICH WAS CUT AT 17 CM SHOWING A V-LIKE SHAPE. IN THE PRODUCT'S IFU WE WARN THAT THE CATHETER MUST NOT BE PULLED BACK THROUGH THE NEEDLE AS CATHETER EMBOLISM NAY BE THE RESULT OF SUCH BEHAVIOR. THE USER SEEMS TO HAVE IGNORED THIS WARNING.
Description of Event or Problem · 1
CATHETER CUT DURING REMOVAL THROUGH NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210130 | EPICUTANEO CAVA CATHETER | SILICONE INTRAVASCULAR CATHETER | LJS | VYGON CORP. | 2184.00 | 280313GE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |