SYNCHRON® SYSTEM PHOSPHORUS REAGENT
Received Aug 26, 2011 · Event occurred Jul 29, 2011
Report 2050012-2011-04723 · MDR key 2224605
Device
Generic name
Phosphomolybdate (colorimetric), Inorganic Phosphorus
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
A09426
Lot number
M104139
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. (BEC) THAT THEY RECEIVED A SHIPMENT OF SYNCHRON SYSTEM PHOSPHORUS REAGENT, AND FOUND THE REAGENT CARTRIDGE LEAKED AND SATURATED THE BOX. BEC CUSTOMER TECHNICAL SUPPORT (CTS) RECOMMENDED THE USE OF PPE BEFORE HANDLING THE LEAKED CARTRIDGE. MSDS WAS REVIEWED, AND THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.
Additional Manufacturer Narrative
REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER. THE ROOT CAUSE FOR THE LEAK IS UNKNOWN. (B)(4).