COULTER® 4C PLUS CELL CONTROL
Received Dec 16, 2010 · Event occurred Nov 16, 2010
Report 1061932-2010-00288 · MDR key 1930221
Device
Generic name
Cell Control
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
7547114
Lot number
NA
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER WAS PROVIDED WITH REPLACEMENT CONTROL.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE 4C PLUS HIGH CONTROL VIAL WAS LEAKING FROM THE CAP AND THE OPERATOR'S FINGER CAME IN CONTACT WITH THE CONTROL MATERIAL WHEN REMOVING THE VIAL FROM THE BOX. THE OPERATOR WAS NOT WEARING GLOVES WHEN THE EXPOSURE OCCURRED, BUT INDICATED THAT THERE WERE NO OPEN WOUNDS ON THE HANDS (CUTS OR SCRAPES). THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES AND MEDICAL ATTENTION WAS NOT SOUGHT. THE OPERATOR DISINFECTED HANDS ACCORDING TO THEIR LABORATORY PROTOCOL.
Remedial action
- Replace