The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot identified one similar complaint from this lot for this potential product quality issue; therefore, it is associated to the exception.The complaint device was not returned to abbott for analysis.Further assessment of the reported issued was conducted.An affiliate in china retrieved 7 sterile devices (5 nc trek and 2 mini trek) through a social media application, wechat, in china as it is possible that the mini trek under investigation was retrieved through the same or similar channel.The purchased units were evaluated for authenticity of design and manufacture by comparing them to verify packaging and labeling materials approved for use by abbott.The chipboard box label number, instructions for use (ifu) number and the pouch label number were recorded for each of the inspected units on the data collection sheet.The recorded data were checked against the corresponding approved documents released in abbott viewpoint and confirmed to be authentic.The verification confirmed that the labels present on the product are consistent with the labels used in the manufacturing process at abbott.Additionally, a thorough investigation performed by abbott west distribution center concluded that the distribution of unregistered mini trek rx could not have been attributed to abbott distribution processes.This conclusion is appropriate because the addendum label for china cannot be printed with mini trek rx part# 1012268-12 and china addendum label build method, is not programmed to include mini trek rx part# 1012268-1.Based on a thorough investigation, it was determined that the distribution of unregistered mini trek rx could not have been attributed to abbott distribution processes.This conclusion is appropriate because the addendum label for china cannot be printed with mini trek rx part numbers and china addendum label build method is not programmed to include mini trek rx part numbers.Therefore, there is no product quality issue with respect to the design, manufacture or labeling of the device.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
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