COULTER RETIC-C CELL CONTROL
Received Oct 7, 2011 · Event occurred Jun 18, 2009
Report 1061932-2011-01653 · MDR key 2320059
Device
Product problems
- Leak/Splash
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE ROOT CAUSE FOR THE LEAK WAS NOT DETERMINED. PRODUCT LABELING CONTAINS SUFFICIENT WARNINGS/PRECAUTIONS ADDRESSING POTENTIAL BIOHAZARD EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.
Description of Event or Problem
THE CUSTOMER HAD CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT ONE (1) VIAL OF THEIR COULTER RETIC-C CELL CONTROL LEAKED FROM THE NEEDLE HOLE IN THE CAP. THERE WAS NO IMPACT TO PATIENT SAMPLE RESULTS OR PATIENT TREATMENT. THE CUSTOMER WAS WEARING PROTECTIVE EQUIPMENT (I.E., LAB COAT AND GLOVES) AT THE TIME OF THE EVENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. MEDICAL ATTENTION WAS NOT SOUGHT. IT IS UNKNOWN IF THE CUSTOMER HAS A RISK MANAGEMENT PLAN IN PLACE FOR THE LABORATORY. IT IS UNKNOWN IF THE CUSTOMER REVIEWED THE MATERIAL SAFETY DATA SHEET (MSDS).