COULTER ACT 5DIFF CONTROL PLUS
Received Aug 19, 2011 · Event occurred Apr 23, 2010
Report 1061932-2011-01205 · MDR key 2256760
Device
Product problems
- Leak/Splash
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED A POTENTIAL BIOHAZARD WHEN ONE VIAL OF COULTER ACT 5DIFF CONTROL PLUS WAS FOUND TO BE LEAKING UPON ARRIVAL. THE OPERATOR WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT OF GLOVES WHEN OPENING THE SHIPPING BOX. IT WAS NOTED THAT THERE WAS A BLOOD SPILL INSIDE THE BOX OF LESS THAN 3 ML. THERE WAS NO EXPOSURE OF MUCOUS MEMBRANES OR OPEN LESIONS TO THE MATERIAL. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.
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." PRODUCT WAS NOT RETURNED FOR EVAL. A REVIEW FOR SIMILAR EVENTS WAS CONDUCTED. THERE HAS BEEN ONLY ONE INCIDENT FOR RECEIPT OF LEAKING CONTROL PLUS VIALS IN THE PAST 12 MONTHS. ROOT CAUSE WAS NOT DETERMINED. PRODUCT LABELING CONTAINS SUFFICIENT WARNINGS/PRECAUTIONS FOR POTENTIAL BIOHAZARD EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.