FDA Adverse Event
Malfunction
Summary report: N
ARTERIAL CANNULA, 19FR
MDR report key: 2003291
·
Received February 28, 2011
Report
- Report Number
- 3008500478-2011-00051
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- January 24, 2011
- Report Date
- February 4, 2011
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DWF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT SAVED BY THE HOSPITAL. A PRODUCT EVALUATION COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT SAVED BY THE CUSTOMER. CURRENT INVESTIGATION DOES NOT INDICATE A MANUFACTURING DEFECT OR A TREND THEREFORE NO CAPA WILL BE INITIATED AT THIS TIME. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE ARTERIAL CANNUAL WAS OPENED, DR. (B)(6) NOTED A GELATINOUS WHITE SUBSTANCE ON THE INNER LUMEN OF THE CANNULA & HAD TO OPEN ANOTHER..
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTERIAL CANNULA, 19FR | ARTERIAL CANNULA | DWF | EDWARDS LIFESCIENCES | AC19 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |