4C PLUS COULTER CELL CONTROL
Received Jun 24, 2011 · Event occurred Jan 9, 2008
Report 1061932-2011-00686 · MDR key 2172317
Device
Product problems
- Break
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE TWO REMAINING CONTROLS WITHIN THE KIT DID NOT EXHIBIT THIS ISSUE. THE PRODUCT WAS DISCARDED BY THE CUSTOMER AND THEREFORE NOT AVAILABLE FOR EVALUATION. THERE HAVE BEEN NO SIMILAR EVENTS 12 MONTHS PRIOR TO THIS EVENT. ROOT CAUSE COULD NOT BE DETERMINED. 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 HAZARD WHEN A PIECE OF GLASS BROKE OFF THE RIM OF A VIAL OF 4C PLUS COULTER CELL CONTROL. THE RIM BROKE WHEN THE OPERATOR WAS REMOVING THE CAP. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND THERE WAS NO INJURY OR EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.