Initial reporter phone #: (b)(6).Results: investigation summary: six 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.Deformed package with open seal.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.Grid mark on bottom web.The bottom web material had melted and it took the shape of the product, thereby causing the package to be forced opened and left an opened seal at the opening tab area.Visual inspection was performed on the returned unit package.Grid mark was observed on the bottom web.This shows that sealing process has been completed and the seal width is within specification.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.) the lot master for batch# 7207496 (catalog #393226) was reviewed.No quality notifications were raised for the vps batch.No abnormalities were observed after reviewing preventative maintenance, calibration and equipment.All sealing process parameter were within validated range.
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