Additional Manufacturer Narrative · 1
RESULTS EVALUATIONS: A SMITHS MEDICAL SALES ACCOUNT MGR WENT TO THIS FACILITY TO SEE THE TECHNIQUE USED BY THE CLINICIAN. THE SITE VISIT REVEALED THAT THE USER WAS NOT PERFORMING THE IN-VEIN ACTIVATION PER THE INSTRUCTIONS FOR USE. A REVIEW OF THE INSTRUCTIONS FOR USE STATES: ONE HANDED TECHNIQUE - GENTLY, PLACE A GAUZE OVER VENIPUNCTURE SITE BEFORE REMOVAL. THEN, USING INDEX FINGER, PLACE GENTLE PRESSURE ON THE FINGER STOP. WITH THE THUMB AND MIDDLE FINGER OF SAME HAND, GRASP THE TUBING BEHIND THE SAFETY DEVICE. GENTLY, PULL BACK ON THE TUBING UNTIL A "CLICK" IS FELT OR HEARD TO ENSURE THAT THE NEEDLE IS FULLY RETRACTED AND LOCKED INTO THE WING BODY. NOTE: DO NOT GRASP THE WING BODY TO SLIDE TOWARD THE NEEDLE. PULL BACK ON THE TUBING AWAY FROM THE CONTAMINATED NEEDLE. OR TWO HANDED TECHNIQUE - PLACE INDEX FINGER BEHIND FINGER STOP ON TOP OF SAFETY DEVICE BEHIND SAFETY STOP. WITH OTHER HAND GRASP TUBING WITH THUMB AND INDEX FINGER AND GENTLY PULL BACK UNTIL "CLICK" IS FELT AND/OR HEARD TO ENSURE THE NEEDLE IS FULLY RETRACTED AND LOCKED INTO THE BODY. THE SALES ACCOUNT MGR HAS PROVIDED THIS FACILITY WITH FULL TRAINING FOR THIS DEVICE.