MalfunctionHAW
NDI PASSIVE SPHERES
Received Jul 11, 2014 · Event occurred Mar 12, 2012
Report 3002743211-2014-00002 · MDR key 4170673
Device
Generic name
Reflective Passive Marker Sphere - Haw, Olo
Manufacturer
Northern Digital, Inc.Model number
8801074Lot number
1201232
Product problems
- Expiration Date Error
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DIFFERENT EXPIRY DATES PRINTED ON OUTER BOX AND INNER POUCH. THIS WAS NOTED DURING INCOMING INSPECTION AT THE USER FACILITY. CUSTOMER RETURNED AFFECTED PRODUCT. INVESTIGATION OF THIS ISSUE DETERMINED THAT LABELS WERE PRINTED INCORRECTLY DURING MANUFACTURE. PROCEDURES WERE UPDATED TO ENSURE EXPIRY DATES ARE CONSISTENT ACROSS ALL LABELS. THIS FAILURE HAS NOT RECURRED SINCE THIS REPORT. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PT WAS HARMED AND NO SERIOUS INJURY OCCURRED.