COULTER® CLENZ AGENT (10 LITERS)
Received Sep 24, 2011 · Event occurred Aug 25, 2011
Report 1061932-2011-01508 · MDR key 2262819
Device
Generic name
General Purpose Reagent
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
8546931
Lot number
102077F
Product problems
- Fluid/Blood Leak
- Loose or Intermittent Connection
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT A CLENZ CONTAINER ARRIVED WITH A LOOSE CAP AND 5 TO 10CC OF THE REAGENT LEAKED. THE CONTAINER DID NOT APPEAR TO BE DAMAGED FROM SHIPMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND LAB COAT AT THE TIME OF THE INCIDENT. NO INJURY OR EXPOSURE WAS REPORTED AND MEDICAL ATTENTION WAS NOT SOUGHT.
Additional Manufacturer Narrative
THE CUSTOMER DISCARDED THE LEAKING CONTAINER. REPLACEMENT PRODUCT WAS SENT TO THE CUSTOMER. (B)(4).