Investigation ¿ evaluation: a review of the manufacturing instructions, quality control, and instructions for use (ifu) of the device was conducted during the investigation.The complaint device has not been returned; therefore no physical examination could be performed.The lot number of the device is not known; accordingly a review of the device history record and complaint history of the lot could not be conducted.The manufacturing documents in place at the time of manufacture were reviewed, and it was found that the device aspect in question was visually inspected by quality control and no notable gaps in production or processing controls were noted.The risk specification for this product includes the separation failure mode and identifies that multiple risk controls are in place to mitigate the risk of this type of failure.The manufacturing process validation for the proximal assembly is validated for both tensile strength and leakage, and includes information to reduce the risk of incorrect flaring or torqueing of the assembly.There is no evidence to suggest that this device was not made to specification.There is no evidence to suggest that nonconforming product are in the field.The root cause is unknown at this time.The product ifu lists warnings and precautions as well as instructions for proper use and placement of this device.The ifu states in the how supplied section, "upon removal from package, inspect the product to ensure no damage has occurred." per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
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