The suspect device was returned for evaluation.Upon visual inspection, the neck flange was found split away from the tube.A split was also found at the swivel connector.The physical characteristics of the split are consistent with damage caused by a sharp object coming into contact with the product.Manufacturing review results confirmed all operations and inspections were conducted and device was manufactured according to standard procedure.If the split had been there prior to product release, it would have been detected and the product would have been scrapped.No evidence was found to suggest the reported event was caused by an intrinsic defect in the product.
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