COULTER AC-T 5 DIFF CONTROL PLUS
Received Sep 16, 2011 · Event occurred Apr 17, 2009
Report 1061932-2011-01453 · MDR key 2267024
Device
Product problems
- Hole In Material
- Leak/Splash
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED ONE VIAL OF THE AC-T 5 DIFF CONTROL PLUS LEAKED FROM THE NEEDLE HOLE ON THE CAP AFTER BEING PIERCED (UNK AMOUNT OF TIMES). FURTHER INFO INDICATED THE LEAK ONLY OCCURRED WHEN THE CONTROL VIAL WAS KEPT IN ROOM TEMPERATURE. THE OTHER VIALS OF THE SAME KIT WERE INTACT. THE POTENTIAL FOR BIOHAZARD EXPOSURE WITH THE REPORTED INCIDENT WAS PRESENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANE OR OPEN SKIN LESION. NO ONE SOUGHT MEDICAL ATTENTION. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT. THE CONTROL KIT WAS REPLACED FOR THE CUSTOMER.
Additional Manufacturer Narrative
PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LAB ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LAB ANALYZER. PICTURES OF THE VIAL WERE RECEIVED FOR EVAL. SERVICE WAS NOT DISPATCHED. ROOT CAUSE COULD NOT BE DETERMINED BASED ON AVAILABLE INFO. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JAN. 1, 2008 AND OCT. 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.