MalfunctionJTL
STA COAG CONTROL N
Received May 19, 2006 · Event occurred Dec 6, 2005
Report 2245451-2006-00001 · MDR key 966370
Device
Generic name
Normal Quality Control Plasma
Manufacturer
Diagnostica StagoModel number
NACatalog number
00676
Lot number
042736
Product problems
- Break
Patient
*
- Dural Tear
- Injury
- Cut(s)
Narrative
Description of Event or Problem
ONE INJURY OCCURRED (A DEEP CUT TO THE THUMB) ON A LABORATORY TECHNICIAN WHILE TRYING TO OPEN CONTROL VIAL. THE ENTIRE TOP BROKE OFF AND THE JAGGED EDGE OF THE REMAINING BOTTLE CUT THROUGH THE GLOVES INTO HER THUMB.