COULTER 5C CELL CONTROL, TRI-PACK

Description of Event or Problem

THE CUSTOMER HAD CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT A VIAL OF THEIR COULTER 5C CELL CONTROL, TRI-PACK LEAKED WHEN THE VIAL WAS TAKEN OUT OF THE REFRIGERATOR AND ALLOWED TO WARM TO ROOM TEMPERATURE. THE CUSTOMER REPORTED THAT THE TOP WAS TIGHT AND THE PIERCE LOCATION WAS IN THE CENTER AREA. THE CUSTOMER REPORTED OBSERVING A BLOOD STAIN ON THE COUNTER WHERE THE VIAL WAS PLACED TO WARM UP. IT IS UNKNOWN WHAT PART OF THE VIAL/TOP WAS LEAKING. 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 REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER REPORTED THAT THE LABORATORY HAS AN EXPOSURE SAFETY OFFICE ON-SITE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED.

Additional Manufacturer Narrative

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. THE ESTIMATED LEAKED VOLUME ON THE COUNTER WAS 0.5 ML. THE CSUTOMER CLEANED THE COUNTER WITH BLEACH AND WATER. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE WAS NOT DETERMINED. PRODUCT LABELING CONTAINS SUFFICIENT WARNINGS/PRECAUTIONS ADDRESSING POTENTIAL BIOHAZARD EVENTS. THIS MDR REPRESENTS EVENT 1 OF 2 REPORTED BY THE CUSTOMER FOR SIMILAR EVENTS. THIS MDR IS RELATED TO THE FOLLOWING MDR THAT HAS BEEN REPORTED: MDR #1061932-2011-01589. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. (B)(4).