4C PLUS COULTER CELL CONTROL
Received Jul 1, 2011 · Event occurred Apr 4, 2008
Report 1061932-2011-00789 · MDR key 2171216
Device
Product problems
- Break
Patient
UNK
- Laceration(s)
Narrative
Additional Manufacturer Narrative
PRODUCT WAS NOT EVALUATED. A COMPLAINT REVIEW WAS CONDUCTED. THERE WERE NO OTHER REPORTED EVENTS FOR 4C PLUS CELL CONTROL VIAL WITH THIS ISSUE WITHIN THE PAST 12 MONTHS. BASED ON THE INFO PROVIDED THE ROOT CAUSE IS MISHANDLING OF PRODUCT. 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 MINOR INJURY WHEN HANDLING THE ABNORMAL CONTROL VIAL OF THE 4C PLUS COULTER CELL CONTROL. THE VIAL BROKE WHEN IT SLIPPED FROM THE OPERATOR'S FINGERS AND FELL ON THE FLOOR. WHILE REMOVING THE BROKEN GLASS FROM THE VIAL, THE OPERATOR CUT HER FINGER ON A SLIVER THAT PENETRATED HER GLOVE. THE WOUND WAS CLEANED PER THE LABORATORY'S PROTOCOL AND NO FURTHER TREATMENT WAS REQUIRED. THE OPERATOR WAS TESTED FOR INFECTIOUS DISEASES PER THE LABORATORY'S PROTOCOL. TESTING WAS NEGATIVE. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.