Investigation could not be performed given that the actual complaint product sample was not provided by the complainant.Smiths medical truly values the input of our customers and is committed to resolving quality related issues without evaluating the actual sample, we can't assess or confirm whether a quality related issue has resulted in the user's reported difficulties.In order to ensure that our products meet functional requirements, the dimensions of the catheter components (eyelet, tubing, and hub) are tightly controlled.During the manufacturing process, our catheters are tested to assure that the tubing will not tear, break or otherwise fail.During the manufacture, critical parameters are 100% controlled during the different phases.Once the catheters are assembled from the tube, eyelet and hub, the catheters are inspected in-process 100% in order to demonstrate that the catheter tube is properly secured to the hub.To further ensure our products meet functional requirements, in-process testing is performed by certified operators using statistically valid sampling plans at defined intervals.If any non-conformances are found, the product is isolated, non-conformed and immediate corrective action is taken.As reported, the reported event could not be verified and/or confirmed with confidence, therefore, no correction, corrective, or preventive actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.Smiths medical regularly reviews and analyzes post-market data for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly.Device history records could not be reviewed given that a lot was not provided.
|