MalfunctionIAF
WRIGHT'S STAIN
Received Jan 30, 2011 · Event occurred Jan 3, 2011
Report 1061932-2011-00042 · MDR key 1973436
Device
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) ON (B)(4) 2011 THAT THE WRIGHT'S STAIN BOTTLE WAS LEAKING AT THE SEAM THERE IS AN EXPOSURE CONTROL PLAN IN PLACE AT THE SITE. THE DAMAGED PRODUCT WAS PROPERLY DISPOSED OF IN BIOHAZARD DRUMS BY THE LAB PERSONNEL. THE CUSTOMER WAS WEARING APPROPRIATE PPE. THERE WAS NO EXPOSURE, OR ANY CONTACT TO EYE OR SKIN, OPEN WOUNDS OR MUCOUS MEMBRANES TO THE WRIGHT'S STAIN.
Additional Manufacturer Narrative
REPLACEMENT PRODUCT WAS SENT ON (B)(4) 2011. ROOT CAUSE IS UNKNOWN.
Remedial action
- Replace