BIG (BONE INJECTION BUG) ADULT MODEL

Additional Manufacturer Narrative

WE MADE MULTIPLE CALLS TO CUSTOMER TO TRY AND UNDERSTAND HOW DEVICE DID NOT FIRE PROPERLY. WE DID NOT OBTAIN THE DEVICE AND THE CUSTOMER JUST EXPLANTED THAT IT DID NOT FIRE. WE TRIED TO TAKE CUSTOMER THROUGH THE STEPS OF USING THE DEVICE TO SEE IF THIS COULD HELP US UNDERSTAND THE STAGE WHEN IT DID NOT FIRE. WITHOUT THE DEVICE AND NOT KNOWING IF LATCH WAS REMOVED TO ALLOW NEEDLE TO FIRE, WE CANNOT CLEARLY ADDRESS THE PROBLEM. WE DID REPLACED PRODUCT AND OFFER RE-TRAINING. WE ASKED ABOUT HANDLING PROCEDURES AND WAS NOT ABLE TO LEARN MORE FROM CUSTOMER TO UNDERSTAND IF HANDLING WAS A REASON. WE DID CHECKED OUR QC PROCESSES AND THE LOT NUMBER FROM THIS COMPLAINT AND COULD NOT REPEAT THE COMPLAINT. WE RECEIVE REPORT OF THE INCIDENT FROM UNITED STATES DISTRIBUTOR (B)(4) 2007. THEY DID NOT RECEIVE THE REPORT FROM END UNDER ON (B)(4) 2007, BUT ON (B)(4) 2007.

Description of Event or Problem

CUSTOMER REPORTED TO DISTRIBUTOR ON INITIAL REPORT THAT DEVICE DID NOT FIRE THE RETRACTED NEEDLE PROPERLY. LEARNED FROM DISTRIBUTOR CALLS TO CUSTOMER THAT THE BIG WAS ATTEMPTED TO BE USED TO GAIN IO ACCESS IN AN EMERGENCY PT AND THE DEVICE DID NOT FIRE PROPERLY. NO OTHER DETAILS WERE GIVEN TO UNDERSTAND THE EXACT MEANING OF THIS STATEMENT. DEVICE WAS PLACED ONTO THE SITE OF THE PT AND PARAMEDIC TRIED TO ACTIVATE IT. THEY DID NOT SEE THE NEEDLE EXIT THE DEVICE. THE CUSTOMER DID NOT KEEP THE DEVICE OR ITS PACKAGING TO RETURN FOR INVESTIGATION.