COULTER 5C CELL CONTROL
Received Nov 4, 2011 · Event occurred Jul 21, 2009
Report 1061932-2011-02037 · MDR key 2339975
Device
Product problems
- Detachment Of Device Component
- Leak/Splash
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. FIELD SERVICE WAS NOT DISPATCHED FOR THIS EVENT. BASED UPON AVAILABLE INFORMATION THE ROOT CAUSE OF THE LOOSE CAP IS UNKNOWN.
Description of Event or Problem
THE OPERATOR REPORTED THAT WHILE MANUALLY MIXING THE 5C ABNORMAL II CONTROL VIAL, THE CAP CAME OFF SPILLING THE REMAINING CONTROL MATERIAL ONTO THE LAB BENCH. THE CONTROL TUBE HAD BEEN ASPIRATED 8 TIMES PREVIOUSLY PRIOR TO SPILLAGE. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (LAB COAT, GLOVES AND SAFETY GLASSES) AT THE TIME OF THE INCIDENT AND THERE WAS NO EXPOSURE OF POTENTIALLY BIOHAZARDOUS TO MUCOUS MEMBRANES OR OPEN LESIONS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION.