TRUCOLOR WRIGHT'S GIEMSA STAIN

Description of Event or Problem

A CUSTOMER REPORTED THAT WHILE EXECUTING PRODUCT RECEIVING ACTIVITIES ON (B)(6) 2011 THEY OBSERVED TWO BOTTLES OF TRUCOLOR WRIGHT'S GIEMSA STAIN LEAKING (VOLUME UNKNOWN) INSIDE THEIR CLEAR PLASTIC BAG. THERE WAS NO HUMAN CONTACT WITH THE FLUID. NO ONE WAS SPLASHED OR SPRAYED. THE HEALTHCARE WORKER INTERFACING WITH THE STAIN WAS WEARING PERSONAL PROTECTIVE EQUIPMENT, WHICH INCLUDED GLOVES, EYE PROTECTION AND A LABORATORY COAT, AT THE TIME OF OCCURRENCE. THERE WAS NO BIOHAZARDOUS EXPOSURE TO HEALTHCARE WORKER UNCOVERED WOUNDS OR MUCOUS MEMBRANES AND NO INJURY WAS REPORTED. NO PERSONNEL SOUGHT ANY MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. NO PATIENT RESULTS WERE AFFECTED BY THIS EVENT. NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. THERE WAS AN EXPOSURE PLAN IN PLACE AT THE FACILITY AND THE MATERIAL SAFETY DATA SHEET WAS AVAILABLE.

Additional Manufacturer Narrative

SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC. REQUESTED PRODUCT EVALUATION INFORMATION FROM THE CUSTOMER. SPECIFICALLY, NO PHYSICAL DAMAGE WAS OBSERVED TO THE OUTSIDE OF THE BOXES IN WHICH THE BOTTLES WERE PACKED. THE CUSTOMER DECLINED TO INSPECT THE STAIN BOTTLE CAPS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.