COULTER ACT 5DIFF CONTROL PLUS
Received Aug 26, 2011 · Event occurred May 12, 2010
Report 1061932-2011-01277 · MDR key 2259962
Device
Product problems
- Leak/Splash
- Loose or Intermittent Connection
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED POTENTIAL BIOHAZARD WHEN THE MID-LEVEL CONTROL VIAL OF THE COULTER ACT 5DIFF CONTROL PLUS KIT WAS FOUND LEAKING. THE LEAK WAS IDENTIFIED WHEN THE KIT WAS OPENED. THE CUSTOMER STATED THAT THE CAP OF THE VIAL WAS LOOSE AND THE VIAL WAS ALMOST EMPTY. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCOUS MEMBRANES. THE CUSTOMER WAS WEARING LAB COAT AND GLOVES. THERE WAS NO MEDICAL TREATMENT REQUIRED. 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. 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 ADDITIONAL REPORTABLE EVENTS.