The customer states a technician was removing an angel wing from its packaging when he noticed the needle was detached from the protective casing.The point supervisor was notified.No patient was involved and no impact to the procedure or clinician.The product was being used for sterility testing on blood sample.The report refers to product code 8881225241- female blood culture transfer with lot number 152190284x.The dhr of the lot number reported was reviewed, and was confirmed that the products were produced accomplishing quality requirements and was released according to established procedures.There was received one sample for evaluation, sample showed that the needle was detached from the holder; it seems that material was not properly assembled during manufacturing process.Root cause could be related to misalignment during the pneumatic press process.A quality circle was opened to follow up this issue, actions were the following: maintenance order to level de press.Personnel were retrained on procedure related to needle press.A poka-yoke was implemented on work station.
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