PROBECHEK MULTIVYSION CONTROL SLIDES
Received Nov 12, 2013 · Event occurred Oct 11, 2013
Report 3005248192-2013-00014 · MDR key 3459846
Device
Generic name
Microscopic Control Slides
Manufacturer
Abbott Molecular, Inc.Catalog number
05J07-01
Lot number
446338
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ABBOTT MOLECULAR, INC. RECEIVED A COMPLAINT FOR PROBECHEK MULTIVYSION CONTROL SLIDES (LIST (B)(4)) REPORTING TWO BROKEN SLIDES WHEN THE SLIDE BOX WAS FIRST OPENED. THERE WAS NO REPORT OF INJURY. IF THIS EVENT WERE TO RECUR, IT IS POSSIBLE THAT A USER COULD BE CUT BY A BROKEN SLIDE AND EXPOSED TO POTENTIALLY INFECTIOUS MATERIAL. THEREFORE, RECURRENCE OF THIS ISSUE COULD POTENTIALLY CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH.
Additional Manufacturer Narrative
A COMPLAINT INVESTIGATION AT ABBOTT MOLECULAR IS IN PROGRESS FOR MDR 300524-2013-00014. AN MDR FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE COMPLAINT INVESTIGATION CONCLUDES. INVESTIGATED W/O DEVICE RETURNED.
Remedial action
- Replace