The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 2/21/2022.H.6.Investigation: two photos and twenty-six actual samples were received by our quality team for evaluation.The first returned photo shows a 22g shelf carton label with batch 1224423.The second returned photo shows a 22g deformed unit package with opening tab near the end cap area.26 actual samples of batch 1224423 were subjected to visual inspection.All samples were observed with a deformed package.17 of the 26 samples were observed with the bottom web of the unit package having shrunk and become deformed near the end cap area of the vps part causing it to be forced open at the opening tab.9 of the 26 samples were observed with the bottom web of the unit package having shrunk and becoming deformed near the protection tube area of the vps part causing it to be forced open.Two of the defect samples (opened tab near the end cap and protection tube) proceeded to further visual inspection of the sealing features.Grid mark was observed on the bottom web showing that the sealing process has been completed and the seal width passed the inspection criteria.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The manufacturing process has been reviewed.There is no process in the manufacturing process that would cause the reported defect.There was no abnormality during the production of the reported batch.Therefore, the reported defect could have occurred out of the manufacturing facility.In addition, a grid mark was observed on the bottom web.This shows that the sealing process has been completed and the seal width is within specification.The probable root cause for the deformed package could be due to the product being exposed to heat during handling (transportation, storage, loading, and unloading, etc).
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