4C PLUS COULTER CELL CONTROL
Received Oct 28, 2011 · Event occurred Jun 15, 2009
Report 1061932-2011-01994 · MDR key 2320289
Device
Product problems
- Break
- Leak/Splash
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
UPON OPENING 4C PLUS CELL CONTROL PRODUCT THAT HAD JUST BEEN RECEIVED BY THE LABORATORY, THE CUSTOMER OBSERVED THAT ONE VIAL OF THE NORMAL CONTROL MATERIAL HAD LEAKED. WHEN EXAMINED BY THE CUSTOMER, THE VIAL WAS SEEN TO BE BROKEN AFTER ITS CAP WAS REMOVED. THERE WAS NO VISIBLE DAMAGE TO THE SHIPPING CONTAINER OR TO THE BOX CONTAINING THE BROKEN VIAL OF CONTROL PRODUCT. IT IS UNKNOWN WHAT PERSONAL PROTECTIVE EQUIPMENT (PPE) THE OPERATOR WAS WEARING; HOWEVER, THE CUSTOMER INDICATED THERE WAS NO EXPOSURE OF POTENTIALLY BIOHAZARDOUS MATERIAL TO MUCOUS MEMBRANES OR OPEN SKIN LESIONS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION.
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 THE TIME OF THE EVENT. FIELD SERVICE WAS NOT DISPATCHED. BASED UPON AVAILABLE INFORMATION, THE ROOT CAUSE OF THE BROKEN VIAL IS UNKNOWN.