4C PLUS COULTER CELL CONTROL
Received Oct 28, 2011 · Event occurred Jun 11, 2009
Report 1061932-2011-01991 · MDR key 2320308
Device
Product problems
- Loose or Intermittent Connection
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. PRODUCT WAS REPLACED AT TIME OF EVENT. FIELD SERVICE WAS NOT DISPATCHED FOR THIS EVENT. BASED UPON AVAILABLE INFORMATION, THE ROOT CAUSE OF THE LOOSE CAP IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE CAP OF THE 4C CELL CONTROL VIAL WAS LOOSE AT FIRST USE. SOME CONTROL MATERIAL ACCIDENTALLY SPILLED ONTO THE FLOOR AND THE OPERATOR'S SHOE. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (LAB COAT, GLOVES AND EYE PROTECTION) AT THE TIME OF THE INCIDENT AND THERE WAS NO EXPOSURE OF POTENTIALLY BIOHAZARDOUS MATERIAL TO MUCOUS MEMBRANES OR OPEN LESIONS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION.