CELL-DYN 16 TRI-LEVEL CONTROL
Received May 24, 2002 · Event occurred Apr 23, 2002
Report 2919069-2002-00005 · MDR key 396435
Device
Generic name
Cell-dyn 16 Tri-level Hematology Control
Manufacturer
Abbott Diagnostic Division/celldynModel number
NACatalog number
99109-01
Lot number
16671
Product problems
- Break
- Crack
Patient
28 YR
- Dural Tear
- Bleeding
- Cut(s)
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
IN 2002 THE CUSTOMER WAS CUT WHILE OPENING THE NORMAL CONTROL VIAL LOT #16671. THE CUSTOMER WAS TAKING THE CAP OFF OF THE VIAL AND THE TUBE CRACKED IN HALF AND CUT THEIR THUMB. THE CUSTOMER WAS WEARING GLOVES. CUSTOMER TOOK OFF THE GLOVES AND RINSED THE CUT WITH 50% BLEACH SOLUTION FOLLOWED BY RINSING WITH WATER UNTIL THE BLEEDING STOPPED. NO FURTHER TREATMENT WAS SOUGHT. NO SERIOUS INJURY WAS REPORTED. THE ACCOUNT STATED THAT THE CONTROL VIAL HAD BEEN PREVIOUSLY OPENED. THE ACCOUNT DISPOSED OF THE CONTROL VIAL. THE ACCOUNT STATED THAT HEPATITIS AND HIV TESTS WERE PERFORMED ON THE TECHNICIAN.