4C PLUS COULTER CELL CONTROL
Received Oct 28, 2011 · Event occurred Jun 16, 2009
Report 1061932-2011-01998 · MDR key 2320296
Device
Product problems
- Fluid/Blood Leak
- Tear, Rip or Hole in Device Packaging
Patient
UNK
- No Patient Involvement
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT AFTER SEVERAL PIERCINGS DURING USE ONBOARD THE ACT DIFF 2 HEMATOLOGY ANALYZER, ONE VIAL OF 4C PLUS CELL CONTROL LEAKED INSIDE ITS PACKAGING WHILE BEING STORED BETWEEN USE IN THE REFRIGERATOR. 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 S EEK MEDICAL ATTENTION.
Additional Manufacturer Narrative
THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. PRODUCT WAS REPLACED AT THE TIME OF THE EVENT. FIELD SERVICE WAS NOT DISPATCHED. BASED UPON AVAILABLE INFORMATION THE ROOT CAUSE OF THE LEAKY VIAL IS UNKNOWN.