COULTER® 4C® ES CELL CONTROL

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) AND REPORTED THAT A SMALL AMOUNT OF BLOOD LEAKED FROM COULTER 4C ES CELL CONTROL TRIPACK. THE LEAK WAS FROM THE PUNCTURE HOLE IN THE LOW CONTROL VIAL TUBE STOPPER. THE LEAK WAS CONTAINED WITHIN THE PLASTIC TRAY SLOT CONTAINING THE LOW CONTROL VIAL. THE LOW CONTROL VIAL HAD BEEN PIERCED 4 TIMES. THE CUSTOMER DISPOSED OF THE LEAKING LOW CONTROL TUBE AND THE CONTAMINATED TRAY. THE CUSTOMER STATED PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS USED WHEN HANDLING THE CONTROL TRAY AND TUBE, AND NO ONE CAME INTO DIRECT CONTACT WITH THE BLOOD LEAK AT ANY TIME. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED, BUT IT IS READILY AVAILABLE. THE LAB'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS EVENT.

Additional Manufacturer Narrative

SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A REPLACEMENT CONTROL KIT WAS SENT TO THE CUSTOMER. A ROOT CAUSE FOR THIS EVENT IS UNKNOWN.