COULTER® CLENZ REAGENT (10 LITER)

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT ONE (1) LEAKING BOTTLE OF COULTER CLENZ REAGENT (10 LITER) UPON RECEIPT OF SHIPMENT. THE CUSTOMER INDICATED THAT THIS INCIDENT WAS A SHIPPING DAMAGE ISSUE. THE PRODUCTS WERE ON A PALLET AND MULTIPLE PRODUCTS WERE WET FROM THE LEAKING REAGENT. THE LOT NUMBER FOR THE LEAKING REAGENT WAS REQUESTED; HOWEVER, THE PACKAGE WAS DAMAGED AND THE LOT NUMBER WAS ILLEGIBLE. SINCE THE LOT NUMBER WAS NOT PROVIDED, THE MANUFACTURING AND EXPIRATION DATE OF THE REAGENT LOT IS UNKNOWN. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE INCIDENT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THIS MDR DOCUMENTS ONE (1) OF TWO (2) REAGENTS LEAKING UPON RECEIPT OF SHIPMENT. MDR 1061932-2011-01820 DOCUMENTS THE OTHER LEAKING REAGENT BOTTLE (COULTER LYSE S III DIFF REAGENT, 5 LITER) AT THIS CUSTOMER SITE.

Additional Manufacturer Narrative

SERVICE WAS NOT DISPATCHED FOR THIS EVENT. REPLACEMENT PRODUCT WAS SENT TO THE CUSTOMER. PER LABELING, 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 ANALYZER. (B)(4).