No visual or functional inspection can be performed since the device sample is not available for evaluation.The device history record (dhr) of the product 031-33j with batch number (b)(4) has been reviewed and was found that the ncmr was opened; for damage during transit.Complete lot was inspected 100% visual inspection.The product was re-inspected and re-packed however this type of defect is easy to detected during the manufacturing of the product since is verified at 100%.Additionally, per internal procedure, distribution center performs 100% inspection as well.Additionally dhr shows that the product was packed and inspected according to our specifications.During the investigation it was found that component tfx-000354 (sheet foam) batch (b)(4) was used during the manufacturing process, this sheet foam was implemented to prevent the product from damage.No conclusion can be established at this time based on the lack of device sample.If the product sample becomes available this complaint will be re-opened.Manufacturing and r&d departments are evaluating the current packaging design, a proposal of a new packaging method has been identified, and therefore a process/design validation has been initiated.Personnel involved on the manufacturing process were notified.
|