MalfunctionCKA
SYNCHRON® CX TOTAL PROTEIN REAGENT
Received Jul 12, 2011 · Event occurred Jun 8, 2011
Report 2050012-2011-02543 · MDR key 2158881
Device
Generic name
Total Protein Test Reagent
Manufacturer
Beckman Coulter, Inc.Catalog number
442740
Lot number
Z102232
Product problems
- Leak/Splash
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER REPORTED TO BECKMAN COULTER, INC. OF A LEAK FROM A BOTTLE OF SYNCHRON CX TOTAL PROTEIN REAGENT. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED, AND MEDICAL ATTENTION WAS NOT SOUGHT. (B)(4) WAS REVIEWED AND THE FACILITY HAS EXPOSURE CONTROL PLAN. THERE WAS NO EFFECT TO PATIENT OR USER.
Additional Manufacturer Narrative
THE CRACK AT THE BOTTOM OF THE BOTTLE CAUSED THE LEAKAGE. PHOTOGRAPHS OF DAMAGED REAGENT KIT WERE RECEIVED. A REPLACEMENT KIT WAS SENT TO THE CUSTOMER.