4C PLUS COULTER® CELL CONTROL
Received Oct 14, 2011 · Event occurred Sep 13, 2011
Report 1061932-2011-01716 · MDR key 2295400
Device
Generic name
Hematology Quality Control Mixture
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
7547114
Lot number
067200
Product problems
- Break
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT A COULTER 4C PLUS CELL CONTROL TUBE WAS LEAKING BLOOD. PER CUSTOMER, THE CAP OF THE LEAKING TUBE APPEARED TO BE DAMAGED. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AT THE TIME OF THE INCIDENT. NO INJURY OR EXPOSURE WAS REPORTED AND MEDICAL ATTENTION WAS NOT SOUGHT.
Additional Manufacturer Narrative
THE ROOT CAUSE OF THE LEAK WAS THAT THE CAP OF THE CONTROL TUBE WAS DAMAGED. THE CUSTOMER WAS SENT A REPLACEMENT SET OF CONTROLS. (B)(4).