SYNCHRON® ASPARTATE AMINOTRANSFERASE PYRIDOXAL-5'-PHOSPHASE (AST) REAGENT
Received Jul 7, 2011 · Event occurred Jun 9, 2011
Report 2050012-2011-02916 · MDR key 2152795
Device
Generic name
Aspartate Aminotransferase Pyridoxal-5'-phosphase Reagent
Manufacturer
Beckman Coulter, Inc.Catalog number
467845
Lot number
M101633
Product problems
- Leak/Splash
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 LEAK FROM A PACK OF SYNCHRON ASPARTATE AMINOTRANSFERASE PYRIDOXAL-5'-PHOSPHASE (AST) REAGENT CARTRIDGES. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED, AND MEDICAL ATTENTION WAS NOT SOUGHT. MSDS WAS REVIEWED AND THE CUSTOMER HAS EXPOSURE CONTROL PLAN IN THE FACILITY. THERE WAS NO EFFECT TO PATIENT OR USER.
Additional Manufacturer Narrative
THE CAP ON THE REAGENT CARTRIDGE WAS INCORRECTLY SCREWED. THE CUSTOMER REQUESTED A REPLACEMENT. THE REAGENT KIT WAS REPLACED.