4C - ES CELL CONTROL
Received Oct 7, 2011 · Event occurred Oct 23, 2008
Report 1061932-2011-01598 · MDR key 2320124
Device
Product problems
- Device Contamination with Body Fluid
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THERE WAS A REPORT FROM THE BECKMAN COULTER INC (BCI) WAREHOUSE, THE (B)(4) DISTRIBUTION CENTER, OF A POTENTIAL BIOHAZARD. IT WAS REPORTED THAT AN INSPECTOR IDENTIFIED DRIED BLOOD ON THE CAP OF A VIAL FROM A KIT OF 4C - ES CELL CONTROL. THERE WERE NO REPORTS OF EXPOSURE, AS THE INSPECTOR WERE WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT. PRODUCT WAS INSPECTED AND IDENTIFIED AT A BCI WAREHOUSE. PRODUCT WAS NOT DISTRIBUTED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
A REVIEW FOR SIMILAR EVENTS WAS CONDUCTED. THIS IS THE ONLY REPORT OF THIS TYPE FOR 12 MONTHS PRIOR TO THE EVENT. ROOT CAUSE WAS NOT DETERMINED. 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.