4C -ES CELL CONTROL
Received Jul 1, 2011 · Event occurred Apr 2, 2008
Report 1061932-2011-00777 · MDR key 2171214
Device
Product problems
- Break
- Fluid/Blood Leak
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CUSTOMER INDICATED THE CAPS ARE BREAKING UP WHEN VIALS WERE CHANGED AND ALSO LEAKING AFTER THE FIRST USE. THE OLD VIAL WAS DISCARDED BY THE CUSTOMER. REQUESTED RETURN OF THE NEW VIAL FOR EVAL. RETURN PRODUCT WAS NOT RECEIVED FOR EVAL. COMPLAINT HISTORY WAS REVIEWED. THERE HAVE BEEN NO COMPLAINTS FOR CAPS BREAKING IN THE PAST 12 MONTHS. THERE IS NO KNOWN ROOT CAUSE FOR THE CAPS OF THE CONTROL VIALS BREAKING. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00787.
Description of Event or Problem
CUSTOMER REPORTED POTENTIAL BIOHAZARD WHEN THE VIALS OF ALL LEVELS OF CONTROLS IN THE 4C -ES CELL CONTROL KIT WERE LEAKING DUE TO BROKEN CAPS. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND OBSERVED HAZARDOUS MATERIAL CLEAN-UP PROCEDURES. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 1 OF 2 EVENTS REPORTED BY THIS CUSTOMER. THE OTHER EVENT IS A MALFUNCTION OF THE ANALYZER USED WITH THESE CONTROLS.