BIG (BONE INJECTION GUN) PEDIATRIC DEVICE

Description of Event or Problem

CUSTOMER REPORTED THAT DEVICE DID NOT FIRE CORRECTLY OUT OF DEVICE. ADDITIONAL CALLS TO CUSTOMER COULD NOT ASCERTAIN MORE DETAILS OTHER THAN DEVICE DIDN'T FIRE PROPERLY. WE DID NOT GET THE DEVICE BACK (IT WAS DISCARDED ALONG WITH PACKAGING) AND WE WERE NOT INFORMED UNTIL (B)(6) 2007 FROM CUSTOMER AND DISTRIBUTOR.

Additional Manufacturer Narrative

REPORT FROM CUSTOMER WAS VAGUE ON ALL ATTEMPTED PHONE CALLS. WE COULD NOT UNDERSTAND WHAT WAS THE DEFINITION OF NOT FIRING PROPERLY. DEVICE HAS SAFETY LATCH THAT NEEDS TO BE REMOVED IN ORDER FOR NEEDLE TO FIRE. CUSTOMER STATES THEY WERE USING IT CORRECTLY. WE DID NOT GET NOTIFIED OF THE EVENT UNTIL (B)(6) 2007. WE INVESTIGATED OUR MANUFACTURING PROCESS, CHECKED VARIOUS LOTS TO SEE IF ANY WERE NOT FUNCTIONING PROPERLY. WE PERFORMED DROP TESTS DIFFERENTLY THAN PREVIOUSLY TO TRY AND CAUSE THE NEEDLE TO DISLODGE FROM INTERNAL HOLDER - AND COULD NOT RECREATE A MISFIRE, DROP TEST OF THE DEVICES IN THEIR BOX COULD NOT RECREATE A LOOSE NEEDLE. WE ARE CHECKING ON POSSIBLE PACKAGING CHANGES TO STRENGTHEN HOLDING THE DEVICE INSIDE THE PACKAGE MAKING ASSUMPTIONS THAT PARAMEDICS HANDLE DEVICES WITH EXTREME ROUGHNESS. WE OFFERED FREE REPLACEMENT OF CUSTOMER'S INVENTORY WITH NEWER STOCK AND OFFER WAS NOT ACCEPTED AT THIS TIME.