4C -ES CELL CONTROL
Received Jul 22, 2011 · Event occurred Jan 12, 2010
Report 1061932-2011-00948 · MDR key 2185188
Device
Product problems
- Break
- Component Falling
- Chemical Spillage
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A REVIEW FOR SIMILAR COMPLAINTS WAS CONDUCTED AND FOUND 4 ADDITIONAL REPORTS OF VIALS BREAKING FROM BEING DROPPED BY CUSTOMERS FROM 2005 TO JANUARY 2010. BASED UPON AVAILABLE INFO, ROOT CAUSE IS THE CUSTOMER DROPPED THE CONTROL BOTTLE AND THE BOTTLE BROKE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.
Description of Event or Problem
CUSTOMER REPORTED A POTENTIAL BIOHAZARD WHEN THE VIAL OF NORMAL CONTROL FROM THE 4C -ES CELL CONTROL KIT FELL AND BROKE WHILE PREPARING THE CONTROL TO BE ANALYZED ON THE COULTER ACT DIFF ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (LAB COAT, GLOVES AND EYE PROTECTION) AT THE TIME OF THE INCIDENT AND THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THE SPILL WAS CLEANED UP WITH BLEACH AND DISPOSED OF IN A BIOHAZARD CONTAINER. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.