COULTER ACT 5DIFF CONTROL PLUS
Received Aug 26, 2011 · Event occurred Apr 29, 2010
Report 1061932-2011-01238 · MDR key 2259819
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 A LOW CONTROL VIAL OF COULTER ACT 5DIFF CONTROL PLUS WAS LEAKING UPON RECEIPT. THE CUSTOMER REPORTED THAT THE VIAL APPEARED TO LEAK (APPROX 1 ML) FROM THE RUBBER STOPPER AND THE CAP OF THE VIAL. THE CUSTOMER WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT OF GLOVES AND LAB COAT DURING THE INCIDENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE LEAKING PRODUCT WAS DISPOSED PER LAB PROTOCOL. 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 LAB ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LAB ANALYZER." PRODUCT WAS NOT RETURNED FOR EVAL. THE PRODUCT WAS DISCARDED BY THE CUSTOMER. 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.