inforMED
MalfunctionCKA

CX SYNCHRON® BLOOD UREA NITROGEN (BUN) REAGENT

Received Jan 20, 2011 · Event occurred Dec 23, 2010

Report 2050012-2011-00146 · MDR key 1965985

Device

Generic name

Blood Urea Nitrogen (bun) Reagent

Model number

N/A

Catalog number

442750

Lot number

M008581

Product problems

  • Device Packaging Compromised

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

A REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER.

Description of Event or Problem

BECKMAN COULTER INC. (BCI) REPORTED THAT THE CX SYNCHRON BLOOD UREA NITROGEN (BUN) REAGENT PACKAGING WAS DAMAGED. NO INJURY WAS REPORTED FOR THIS EVENT.