The problem was detected at the distributor site during the inspection prior to the distribution of the device in the market.The manufacturer performed dhr review of the complaint lot 659821.There were found no non-conformities or abnormalities in the records.Affected sample was not returned for an evaluation as it was discarded by the distributor.From the pictures sent by the distributor it can be seen, there is no sign of sealing on the pouch visible (no deformations, heat maps, etc.).That means no pressure and/or temperature impacted the pouch, so it is evident the packed device could not be inserted into the sealer and had to skip this operation.A material flow in current manufacturing processes was verified.No observation was found.The operators work in accordance with applicable working instructions and line clearance rules.A review of quality system data was done.Neither customer complaint, nor non-conformance was found for this kind of product in last 3 years which is a shelf life of the device.All data signals there is no systemic root cause, most likely this is a single occurrence of the root cause which relates to the organization of the work on the sealing table when the operator inserted non-sealed pouch to completed products.Manufacturing lot 659821 was manufactured prior to the implementation of the sensor for counting of performed seals on the sealers to prevent similar issue.
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