Other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Four shelf cartons of thirty-six samples were returned inside of a plastic bag which it is not their original packaging.Visual inspection did not observe any damage or bent condition of the pouches inside of the self carton, however out of the shelf cartons were observed and received damaged.The shelf carton is packaged inside of transit cartons to protect from damage, and all transit cartons have corner protection with a mesh to ensure products aren't damaged while transported.It was concluded that failure reported could not be reproduced in the packaging process; therefore the damage was after the product left manufacturing facilities.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.
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