COULTER 5C CELL CONTROL
Received Sep 23, 2011 · Event occurred May 15, 2009
Report 1061932-2011-01487 · MDR key 2276806
Device
Product problems
- Detachment Of Device Component
- Material Puncture/Hole
Patient
UNK
- No Known Impact Or Consequence 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. THE SHAPE OF THE TRACK INSIDE THE CAP APPEARED TO BE FLAT WITH A RELATIVELY SHALLOW GROOVE. THE OTHER VIALS OF THIS PRODUCT AT THE SITE WERE VISUALLY EXAMINED AND APPEARED TO BE SATISFACTORY. THE SUSPECT PRODUCT WAS REPLACED AT THE TIME OF THE EVENT. THE ROOT CAUSE WAS A VIAL CAP WITH AN ABNORMAL APPEARANCE.
Description of Event or Problem
THE CUSTOMER REPORTED THAT A SINGLE 5C CELL CONTROL (ABNORMAL I) VIAL CAP CAME OFF AFTER SEVERAL PUNCTURES FROM THE INSTRUMENT. THERE WAS NO MATERIAL SPILL OR LEAK. THE VIAL CAP GROVES WERE DESCRIBED AS SHALLOW AND FLAT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE INCIDENT AND THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION.