Actual device was returned for investigation on 10/30/2015.Facility indicated package was opened and end of device fell off.Device never used on patient.Rwmic received device, with tip off, and upon visual inspection found a small amount of solder.Amount of solder was insufficient in order to maintain an intact device during normal use.Manufacturing records revealed one individual performed the soldering step for this device lot.Manufacturing instructions to be reviewed with individual to assure manufacturing steps are clearly understood.Remaining inventory to be visually inspected as well as stress tested to verify sufficient amount of solder used on any remaining devices.Two similar issues have occured (mdr1418479-2015-00041 and mdr1418479-2015-00042).Rwmic considers this report closed.
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