THE CUSTOMER HAS CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT A HIGH CONTROL VIAL FROM A SHIPMENT OF COULTER 4C PLUS CELL CONTROL TRI-PACK WAS LEAKING UPON RECEIPT. THE CUSTOMER REPORTED THAT THE CONTENTS OF THE HIGH CONTROL VIAL WERE HEMOLYZED UPON RECEIPT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. THERE WAS NO LEAK OF THE HIGH CONTROL VIAL ON THE COUNTER OR THE FLOOR. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER WAS UNSURE IF THE LABORATORY HAS A SPILL CONTROL PROCEDURE IN PLACE. IT IS UNKNOWN IF THE LABORATORY HAS A RISK MANAGEMENT PLAN IN PLACE. IT IS UNKNOWN IF THE CUSTOMER REVIEWED THE MATERIAL SAFETY DATA SHEET (MSDS) AT THE TIME OF THE EVENT.
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PRODUCT LABELING STATES: "BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER." SERVICE WAS NOT DISPATCHED FOR THIS EVENT. PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE WAS NOT DETERMINED. PRODUCT LABELING CONTAINS SUFFICIENT WARNINGS/PRECAUTIONS ADDRESSING POTENTIAL BIOHAZARD EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.