A visual inspection was performed on the returned device.The reported complaint was confirmed.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 identified no other similar incidents and/or complaints from this lot.The investigation determined the reported complaint appears to be related to operational context.All currently available evidence points to the placement of the 2.75 x 15 mm nc trek bdc in the chipboard box for a 2.75 x 8 mm nc trek bdc having occurred at the account.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device as the respective lots were manufactured approximately ten months apart on different production lines and were never at the distribution centers at the same time, which indicates the two units involved in this complaint never came into contact with one another during production.
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