The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 05-may-2022.H.6.Investigation: one actual sample of batch 1203323 were received by our quality team for evaluation.The returned sample was subjected to visual inspection and penetration testing.From the sample, the team observed that the bottom web of the unit package had shrunk and become deformed near the end cap area of the venflon pro safety part causing it to be forced open at the opening tab.The returned sample passed the penetration testing, and no blunt needle was observed.Further visual inspection of the sealing features was performed, and a grid mark was observed on the bottom web.This shows that the sealing process was 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 was reviewed.There is no part of the manufacturing process that would cause the reported defect.Based on the defect simulation performed on similar packaging materials, the product could have been subjected to a temperature up to 80 degrees celsius.There is no process during manufacturing that could cause the product to be exposed to such temperatures.The probable root cause for the deformed package could be due to the product being exposed to heat during handling (cargo transportation, storage, loading and unloading, etc).
|