COULTER® 4C® PLUS CELL CONTROL

Additional Manufacturer Narrative

THE CUSTOMER STATED THE VIAL WAS OPENED ON MARCH 7TH AND THE LEAKAGE OCCURRED ON MARCH 15TH. THE VIAL HAD BEEN PIERCED SIX TIMES. THE CUSTOMER STATED THAT UPON INSPECTION, THE PUNCTURE HOLE ON THE CAP OF THE LOW VIAL LOOKED SLIGHTLY LARGER THAN THOSE FOR THE NORMAL AND HIGH CONTROLS. THE ROOT CAUSE IS ATTRIBUTED TO THE SIZE OF THE PUNCTURE HOLE ON THE CAP OF THE 4C PLUS LOW CONTROL. A COURTESY REPLACEMENT WAS SENT TO THE CUSTOMER. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A COULTER 4C PLUS CELL LOW CONTROL VIAL THAT LEAKED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. THERE WAS NO EXPOSURE, OR CONTACT WITH EYES OR SKIN, OPEN WOUNDS OR MUCOUS MEMBRANE. THE MSDS WAS REVIEWED BY THE TECHNICIAN. THERE IS AN EXPOSURE CONTROL AND RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.