General information: we received a complaint about gaps in the solder at six needle holders noticed during incoming goods inspection at the customer.Consequences for the patient: according to the available information, there were no negative consequences for the patient.Investigation: investigation was carried out by ats.According to the qstd, the soldering must be complete filled and even.Batch history review: the device quality and manufacturing history records will be checked for the lot number 4510838636 from the quality coordinator of the production plant.The results of the review will be documented in (b)(4).If the review shows any conspicuities, the report will be updated and actions will be initiated.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to a manufacturing error.Rationale: according to the qstd, the soldering must be free of gaps.Therefore this/these needle holders should not have passed the final inspection.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.
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