KIT CWS I/NAOH-D/BASIC WASH
Received Dec 13, 2012 · Event occurred Nov 29, 2012
Report 1823260-2012-06312 · MDR key 2871408
Device
Generic name
Sodium Hyroxide Solution
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04880285190
Lot number
10209700
Product problems
- Device Ingredient or Reagent Problem
Patient
Not reported
- Caustic/Chemical Burns
Narrative
Description of Event or Problem
WHILE REPLACING THE NAOH-D (CELL WASH 1) SOLUTION ON THE MODULAR CORE ANALYZER, SERIAL NUMBER (B)(4), THE CUSTOMER WAS KNEELING ON THE FLOOR AND WAS POURING LIQUID FROM ONE BOTTLE TO ANOTHER. THE BOTTLE SLIPPED FROM HER HANDS AND THE SOLUTION SPLASHED IN HER FACE. THE CUSTOMER STATED THERE WERE NO ISSUES WITH THE BOTTLE. THE CUSTOMER HAD FIRST DEGREE BURNS TO FACE AND RIGHT EYE AND WAS TREATED IN THE EMERGENCY ROOM. THE EMERGENCY ROOM FLUSHED THE AFFECTED AREAS WITH COLD WATER AND TREATED HER WITH OINTMENT FOR FACE AND EYE. THE CUSTOMER'S CURRENT CONDITION WAS "FULLY HEALED". THE CUSTOMER WAS WEARING CONTACTS WHEN THE INCIDENT OCCURRED, BUT WAS NOT WEARING ANY PERSONAL PROTECTIVE EQUIPMENT.
Additional Manufacturer Narrative
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THE CAUSE OF THE EVENT WAS A CUSTOMER HANDLING ERROR. PRODUCT LABELING INSTRUCTS THE CUSTOMER NOT TO POOL SOLUTIONS TOGETHER. ALSO, PROTECTIVE CLOTHING AND EQUIPMENT SUCH AS SAFETY GLOVES OR GLASSES SHOULD BE WORN WHEN WORKING IN A LABORATORY.