SEDIPLAST AUTOZERO WESTERGREN ESR SYSTEM
Received Oct 14, 2014 · Event occurred Oct 3, 2014
Report 2435505-2014-00001 · MDR key 4308389
Device
Product problems
- Use of Device Problem
- Improper or Incorrect Procedure or Method
Patient
UNK
- Exposure to Body Fluids
Narrative
Description of Event or Problem
POLYMEDCO RECEIVED A CUSTOMER CALL STATING THAT WHILE ONE OF THEIR LAB TECHS WAS INSERTING A SEDIPLAST PIPETTE INTO THE BLOOD FILLED VIAL, THE TOP OF THE PIPETTE POPPED OFF AND BLOOD SPRAYED OUT. THE LAB TECH WAS NOT WEARING ANY FACIAL PERSONAL PROTECTIVE EQUIPMENT OR USING A LAB SHIELD. THE LAB TECH WAS SPRAYED IN THE FACE WITH BLOOD, SENT TO THE EMERGENCY ROOM FOR A BODILY FLUID EXPOSURE WORKUP AND RELEASED. (B)(4).
Additional Manufacturer Narrative
A (B)(4) SEDIPLAST PIPETTES WERE DISTRIBUTED IN THE US MARKET IN 2014 YTD AND THERE WERE NO OTHER INCIDENTS OF THIS NATURE. IN 2013, A SAFETY ALERT WENT OUT HIGHLIGHTING THE INSTRUCTIONS FOR USE. THE INSTRUCTIONS FOR USE STATE THAT IT IS IMPORTANT TO CAREFULLY AND GENTLY INSERT THE PIPETTE INTO THE BLOOD FILLED VIAL, WITHOUT HOLDING OR BLOCKING THE TOP OF THE PIPETTE. FROM 2013-2014 YTD, (B)(4) SEDIPLAST PIPETTES WERE DISTRIBUTED. AN INVESTIGATION IS CURRENTLY UNDERWAY TO DOCUMENT THE PROBABLE ROOT CAUSE OF THE INCIDENT AND ASSESS IF THERE IS ANY NECESSARY CORRECTIVE ACTION OR SAFETY ALERT REQUIRED.
Remedial action
- Inspection