(b)(4).The sample was not returned for evaluation.The manufacturer reports that "while we were not able to determine a specific cause for the bond failure, please be advised that salter labs has long used several in-process manufacturing controls to assure the quality and strength of our cannula bonds.This includes, but is not limited to, extensive operator training, custom fixtures to control solvent dipping length, and routine sample testing of bond strengths throughout each shift, utilizing both non-destructive and destructive test methods." if the sample is returned, a follow-up report will be submitted with investigation results.
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