OtherGMP
RPR CONTROL CARDS 18MM CIRCLE CONTROLS
Received Sep 23, 1999 · Event occurred Aug 26, 1999
Report 1119779-1999-00005 · MDR key 241959
Device
Generic name
Antisera, Control For Nontreponemal Tests
Manufacturer
Becton DickinsonModel number
NACatalog number
4976709
Lot number
D903
Product problems
- Improper or Incorrect Procedure or Method
Patient
UNKNOWN
- Exposure to Body Fluids
- Other (for use when an appropriate patient code cannot be identified)
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
USER REPORTED A POTENTIAL EXPOSURE TO THE CONTROL/ANTIGEN MIXTURE FROM THE RPR CONTROL CARD KIT. DUE TO USER CARELESSNESS, THERE WAS EXPOSURE TO THE EYE OF CONTROL MATERIAL THAT CONTAINS SCREENED HUMAN PLASMA. USER FLUSHED EYE WITH WATER AND WAS EXAMINED BY A DR. USER IS REPORTED TO BE IN GOOD HEALTH. BECAUSE USER IS 6 WEEKS PREGNANT, A FILLING IS BEING MADE AS A PRECAUTION ONLY, EVEN THOUGH NO MALFUNCITON OF THE DEVICE IS INDICATED.