COULTER® 4C® PLUS CELL CONTROL
Received Jan 5, 2011 · Event occurred Dec 8, 2010
Report 1061932-2011-00005 · MDR key 1949925
Device
Generic name
Hematology Quality Control Mixture
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
7547114
Lot number
084500
Product problems
- Break
- Component Falling
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A COULTER 4C PLUS CELL NORMAL CONTROL TUBE THAT FELL AND BROKE. THE CUSTOMER WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT, AND THERE WAS NO INJURY. THERE WAS NO EXPOSURE TO OPEN LESION OR MUCOUS MEMBRANES, AND NO ONE SOUGHT MEDICAL ATTENTION. MSDS WAS REVIEWED, AND THE CUSTOMER HAS AN EXPOSURE PLAN IN PLACE WITHIN THE LAB.
Additional Manufacturer Narrative
SERVICE WAS NOT DISPATCHED FOR THIS EVENT.THE CUSTOMER WAS ADVISED TO CALL THEIR DISTRIBUTOR TO GET NEW CONTROLS. THE ROOT CAUSE FOR THIS EVENT WAS A DROPPED TUBE.
Remedial action
- Other