Qn#(b)(4).The analysis received from the manufacturing site (galemed) reports: 1.) check the production information of the customer complaint batch (lot# 201207 & 210215), there is no related abnormal records.2.) the customer's sample cannot be sent back due to local control, and the photos provided are too vague for more specific analysis.3.) all mask must be test the leakage in produce process.Obviously, if the crack is so large, it cannot pass the leakage test.4.) according with the information share by customer and the configuration of the material in the box didn't correspond to cracking so large when the package is opened." it was also reported , "we speculate that the operator did not use the correct method to remove burrs from the product during the manufacturing process.As a result, the welding strength of the product at this position is reduced.However, there was no immediate crack in the production process, so the leak test in the plant was qualified.In the process of transportation, the product may be subjected to large vibration or impact, resulting in deterioration or damage of this position.Galemed has reported that corrective actions have been taken.
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