MalfunctionCKA
SYNCHRON CONTROLS (LEVELS 1-3)
Received Dec 10, 2010 · Event occurred Nov 28, 2010
Report 2050012-2010-01646 · MDR key 1918976
Device
Generic name
Control Multi-level
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
657365 (FOR REAGENT PACK)
Lot number
M909750
Product problems
- Loose or Intermittent Connection
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS DISCOVERED IN THE (B)(4) THAT SYNCHRON CONTROL MULTI-LEVEL BOTTLES HAD LOOSE CAPS. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS EVENT.