VITAL*VUE
Received Dec 4, 2012 · Event occurred Nov 7, 2012
Report 2890526 · MDR key 2890526
Device
Product problems
- Device Contamination with Chemical or Other Material
Patient
55 YR
- No Patient Involvement
Narrative
Description of Event or Problem
OPENED STERILE PRODUCT & SAW A HAIR WRAPPED AROUND A BALL OF LINT INTERTWINED IN TUBING. PRODUCT WAS REMOVED FROM THE STERILE FIELD AND ANOTHER ONE OPENED. THIS PRODUCT HAD NO CONTACT WITH THE PATIENT. MANUFACTURER RESPONSE FOR VITALVUE SUCTION HAND PIECE, VITAL*VUE (PER SITE REPORTER)TOOK DOWN DESCRIPTION OF PROBLEM, ISSUED COMPLAINT # XXX AND ARE SENDING A RETURN KIT SO PRODUCT CAN BE RETURNED FOR INSPECTION...REC'D RETURN KIT & SHIPPED OUT.