COULTER CLENZ® CLEANING AGENT
Received Oct 5, 2010 · Event occurred Sep 8, 2010
Report 1061932-2010-00163 · MDR key 1853408
Device
Generic name
Cleaning Agent
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
8546931
Lot number
102020F
Product problems
- Leak/Splash
- Device Damaged Prior to Receipt by User
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A SHIPPING BOX OF COULTER CLENZ CLEANING AGENT THAT WAS DAMAGED AND LEAKING UPON RECEIVING. LESS THAN 15 ML OF THE CLENZ AGENT WAS CLEANED UP WITH PAPER TOWELS. PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS NOT IN USE, BUT THERE WAS NO EXPOSURE OF CLENZ AGENT TO EYES, MOUTH, OR OPEN WOUNDS. NO DEATH OR INJURY WAS ASSOCIATED WITH THIS EVENT. NO ONE SOUGHT MEDICAL ATTENTION.
Additional Manufacturer Narrative
A REPLACEMENT CLENZ AGENT WAS SENT TO THE CUSTOMER. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.
Remedial action
- Replace