CONTRAD 70

Additional Manufacturer Narrative

BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PHOTOS REVEALED THAT THERE WAS NO SHIPPING DAMAGE TO THE AFFECTED BOTTLE. NO ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT TO DATE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY OBSERVED A LEAK COMING FROM A BOTTLE OF CONTRAD 70. THE LEAK WAS OBSERVED AT A DEALER FACILITY. IT IS UNKNOWN AS TO WHETHER PERSONNEL INTERFACING WITH THE CONTRAD 70 WERE WEARING PERSONAL PROTECTIVE EQUIPMENT HOWEVER, THERE WAS NO REPORT OF ANY PERSONNEL SEEKING MEDICAL ATTENTION ASSOCIATED WITH THIS EVENT. NO PATIENT RESULTS WERE INVOLVED IN THIS EVENT. THERE WAS NO MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THERE WAS NO CHEMICAL/BIOHAZARDOUS EXPOSURE TO PERSONNEL UNCOVERED WOUNDS OR MUCOUS MEMBRANES AND NO INJURIES WERE REPORTED. THE AMOUNT OF LEAKAGE FOR THIS EVENT COULD NOT BE DETERMINED. ALTHOUGH THE FLUID VOLUME OF THE CONTRAD 70 CONTAINER IS THEORETICALLY SIGNIFICANT ENOUGH TO CAUSE A SLIPPING HAZARD IF IT IS SPILLED, THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THERE WAS AN EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY AND THE MATERIAL DATA SAFETY SHEETS WERE REVIEWED.