BIG (BONE INJECTION GUN) PEDIATRIC MODEL

Description of Event or Problem

INITIAL REPORT FROM DISTRIBUTOR STATED THAT THE BIG WAS ATTEMPTED FOR USE TO GAIN IO ACCESS IN AN EMERGENCY PT AND THE DEVICE DID NOT FIRE PROPERLY. IT WAS STATED THAT THE NEEDLE WAS RETRACTED INSIDE THE DEVICE AND DID NOT COME OUT. DEVICE WAS PLACED ONTO THE SITE OF THE PT AND PARAMEDIC TRIED TO ACTIVATE IT. THEY DID NOT SEE THE NEEDLE EXIT THE DEVICE.

Additional Manufacturer Narrative

WITH FURTHER CALLS TO THE END USER WE TRIED TO OBTAIN MORE DESCRIPTIVE DETAILS. WE ASKED ABOUT HOW THE DEVICE WAS USED. WE ASKED ABOUT THE STEPS TAKEN TO USE THE DEVICE. IT WAS UNCLEAR FROM THE CUSTOMER WHETHER THE SAFETY LATCH HAD BEEN REMOVED BEFORE ACTIVATING DEVICE. WITHOUT SAFETY LATCH REMOVED, YOU CANNOT FIRE DEVICE. IT SEEMS THAT THE USER MAY NOT HAVE REMOVED THE SAFETY LATCH BEFORE OPERATING, THEREFORE THE DEVICE WAS NOT TRIGGERED TO DISCHARGE THE NEEDLE. THE USER DISCARDED DEVICE AND DIDN'T SEND IT FOR INSPECTION. WE OFFERED RE-TRAINING TO THE CUSTOMER. WE REPLACED PRODUCT WITH NEW AS GOODWILL GESTURE. WE ASKED CUSTOMER TO PROVIDE US MORE INFO FROM FIELD PERSONNEL WHO ACTUALLY USED DEVICE ON DATE OF INCIDENT TO FURTHER PROVIDE US WITH STEPS USED. WE DID NOT RECEIVE REPORT OF THE INCIDENT FROM UNITED STATES DISTRIBUTOR AND CUSTOMER UNTIL (B)(4) 2007. DISTRIBUTOR DID NOT RECEIVE THE REPORT FROM END USER (CUSTOMER) ON (B)(6) 2007 BUT ON (B)(6) 2007. WE HAVE ATTEMPTED MANY TIMES WITHIN THE LAST 30 DAYS TO OBTAIN MORE DETAILS SINCE THE INITIAL REPORT FROM CUSTOMER IS SO VAGUE AND DID NOT PROVIDE US SIGNIFICANT INFORMATION TO CONDUCT THOROUGH INVESTIGATION WITHOUT ACTUAL DEVICE RETURNED.