COULTER ACT RINSE SHUTDOWN DILUENT
Received Jul 22, 2011 · Event occurred Dec 22, 2009
Report 1061932-2011-00918 · MDR key 2185199
Device
Product problems
- Break
- Leak/Splash
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A REVIEW FOR SIMILAR EVENTS WAS CONDUCTED. THERE HAS BEEN ONLY ONE ADDITIONAL REPORT OF REAGENT LEAKING UPON RECEIPT DURING 2004 TO 2009. ROOT CAUSE IS UNKNOWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.
Description of Event or Problem
CUSTOMER REPORTED A POTENTIAL CHEMICAL HAZARD WHEN THE COULTER ACT RINSE SHUTDOWN DILUENT WAS LEAKING. THE PACKAGE HAD A BROKEN SEAL AND WAS LEAKING UPON RECEIPT. THE OPERATOR WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE INCIDENT. THERE WAS NO SPILL ON THE FLOOR OR COUNTER AND NO REAGENT MATERIAL SPILLED ON THE OPERATOR. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES, SKIN, EYES OR INHALATION. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.