BIG (BONE INJECTION GUN) ADULT MODEL

Description of Event or Problem

PARAMEDIC ON SITE STATED THAT DURING TREATMENT OF A PT IN CARDIAC ARREST, VEIN LINE ATTEMPTS FAILED THEREFORE HE DECIDED TO ESTABLISH AN IO LINE. CUSTOMER REPORTED THAT WHEN OPENING THE DEVICE PACKAGE, THE NEEDLE WAS NOT ATTACHED (WAS LOOSE) FELL OUT OF PACKAGE PRIOR TO USE. DEVICE WAS NEVER USED ON PT.

Additional Manufacturer Narrative

CUSTOMER CONTACTED DISTRIBUTOR (B)(6) 2007 TO REPORT DEVICE FAILURE. DISTRIBUTOR CONTACTED MANUFACTURER (B)(6) 2007. WAISMED HAS BEEN TRYING TO RECREATE BY MANY DIFFERENT TESTS AND ANALYSIS. WE HAVE INVESTIGATED PACKAGING, EXTREME HANDLING, DROP TESTS, ORIGINAL ASSEMBLY DESIGNS. ALL OF THESE ARE BEING LOOKED AT TO SEE IF FAILURE CAN BE RECREATED. WE HAVE NOT RECREATED NEEDLE FALLING OUT. HOWEVER, WE ARE WORKING TO IMPROVE PACKAGING SINCE PARAMEDICS HANDLING CAN BE ROUGH. NEW PACKAGING SAMPLES HAVE BEEN ORDERED TO SEE IF THE PACKAGE CAN BE AN IMPROVEMENT. REVIEW OF INTERNAL NEEDLE HOLDING MECHANISM HAS BEEN CHECKED AND THE ASSEMBLY PROCESS REVIEWED. INCREASED FINISHED GOODS QC CHECKS HAVE BEEN IMPLEMENTED. WE HAVE RECOMMENDED TO THE CUSTOMER TO CARRY TWO DEVICES AS BACKUP SINCE CUSTOMER STATED THEY DID NOT HAVE SECOND UNIT IN THEIR BAG. CUSTOMER HAS IMPLEMENTED NEW PROTOCOL TO HAVE VARIOUS BACKUP EQUIPMENT FOR IO ACCESS.