4C PLUS COULTER CELL CONTROL
Received Aug 12, 2011 · Event occurred Mar 14, 2010
Report 1061932-2011-01133 · MDR key 2229280
Device
Product problems
- Fluid/Blood Leak
- Loose or Intermittent Connection
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
TORQUE TEST RECORDS FOR THE VIAL LOTS IN THIS KIT DEMONSTRATED PASSING RESULTS. A REVIEW FOR SIMILAR EVENTS WAS CONDUCTED. THERE HAVE BEEN FOUR REPORTS OF LEAKING FOR THIS PRODUCT FROM 2005 TO 2010. ROOT CAUSE WAS NOT DETERMINED. 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 CONTROL VIALS OF A 4C PLUS COULTER CELL CONTROL KIT WERE FOUND TO BE LEAKING. A SMALL AMOUNT OF THE CONTROL LEAKING ONTO THE VIAL CAPS WHILE STILL INSIDE THE CONTAINER. THIS APPEARED TO BE DUE TO LOOSE VIAL CAPS. THE OPERATOR WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT OF GLOVES AND SAFETY GLASSES. THERE WAS NO EXPOSURE OF THE MATERIAL TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.