Investigation - evaluation: a review of the documentation, instructions for use (ifu) and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.A customer provided image of the device shows what appears to be the hub snapped in half where the threads attach to the locking mechanism.Additionally, a document based investigation evaluation was performed.Based on the review of current documentation, inspection activities are in place to prevent the release of nonconforming product related to the reported failure mode.A review of the device history record was unable to be conducted due to an unknown lot number.The instructions for use (ifu) advise the user to inspect the device prior to use to ensure that no damage has occurred.There is no additional information regarding maintenance of the device.It would require a great deal of force to snap this device in half.It is unlikely that normal care of the device or normal tension from drainage bags could cause this.At this time, the most probable cause is device failure related.However, an attempt to alter the device or attempt to unscrew the device at the threads cannot be entirely ruled out.Based on the information provided, no returned product and the results of our investigation, a likely cause could be traced to a component failure although this could not be confirmed.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.
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