6v.Investigation: 12 actual samples were returned for the investigation of this complaint.The bottom web of the unit package had shrunk and become deformed near the end cap area of the vps part causing it to be force opened at the opening tab.Visual inspection was performed on the sealing features of the returned samples.Grid mark was observed on the bottom web.This shows that sealing process has been completed and the seal width is within specification.1 photo was returned for the investigation of this complaint.From the photo, it appeared that the packaged had been subjected to high temperature which causes the bottom web to shrink and become deformed near the end cap area of the vps part causing it to be force opened at the opening tab.There is no process in the manufacturing facility that could cause this nonconformance.There was 100% sorting done on sterile parts for this affected batch prior to shipment.Based on the above investigation result, the reported nonconformance occurred after the product was packed in our manufacturing and sterilization process.Therefore, the probable root cause could be due to temperature gradient experience by the product during handling (transportation, storage, loading and unloading, etc.).
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