COULTER BODY FLUID CONTROL
Received Oct 7, 2011 · Event occurred Jun 22, 2009
Report 1061932-2011-01652 · MDR key 2320081
Device
Product problems
- Fluid/Blood Leak
- Hole In Material
Patient
UNK
- No Patient Involvement
Narrative
Description of Event or Problem
WHILE EVALUATING AN ANALYZER AT THE CUSTOMER'S LABORATORY, A BECKMAN COULTER, INC. (BEC) APPLICATIONS SPECIALIST OBSERVED THAT ONE (1) OF THE FOUR (4) COULTER BODY FLUID CONTROL VIALS HAD A PIN HOLE ON THE BOTTOM OF THE VIAL ALLOWING THE CONTROL FLUID TO LEAK OUT. THE CUSTOMER WAS NOT INVOLVED WITH THIS EVENT. THE LEAKING CONTROL VIAL WAS DISCOVERED BY A BEC APPLICATIONS SPECIALIST WHILE CONDUCTING POST-INSTALLATION EVALUATION OF THE CUSTOMER'S ANALYZER. THE BEC APPLICATIONS SPECIALIST WAS WEARING PERSONAL 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 WA NOT SOUGHT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE BEC APPLICATIONS SPECIALIST AT THE TIME OF THE EVENT.
Additional Manufacturer Narrative
THE ROOT CAUSE OF THE PIN HOLE IN THE CONTROL VIAL 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.