BODY FLUID CONTROL

Description of Event or Problem

BECKMAN COULTER WAREHOUSE IN (B)(6) REPORTED THAT THE DXH BODY FLUID CONTROL WAS LEAKING FROM THE TOP OF THE SECOND LEVEL OF THE BODY FLUID CONTROL TUBE. THE LEAK WAS NOTICED WHILE CONTROL VIALS WERE STILL IN THE PACKING BOX. THERE WAS NO VISIBLE DAMAGE TO THE PACKAGE. THE STAIN WAS NOTICED ON THE OUTSIDE OF THE PACKAGE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING A LAB COAT, MASK AND EYE SHIELD. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THERE WAS NO DEATH, INJURY OR AN EFFECT TO PATIENT TREATMENT.

Additional Manufacturer Narrative

FIELD SERVICE WAS NOT REQUESTED FOR THIS EVENT. FAILURE MODE OF THIS EVENT IS A LOOSE CAP ON BODY FLUID CONTROL SHIPMENT. 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 IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).