Investigation summary: the device history report for lot number 7304699 was reviewed, no related abnormalities were found.Material number 395095 for lot 7304699 was manufactured on 11/05/2017.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.Additionally a photograph was submitted for the purpose of aiding in our quality engineers investigation, the provided photograph displayed a kinked extension tube, no additional damage such as cracks as or leakage were noted during the course of our investigation.The most likely root cause for this complaint is product design.The kinked tubing is inherent to the packaging process as a direct result of the length of the component extension tubing.This issue is not associated with damage, cracks, or leakage.Investigation conclusion: based on investigation results to date, root cause is associated to the manufacturing process (inherent product condition).
|