Investigation summary: four pictures and the affected sample was received by our quality team for investigation.Upon visual inspection of the sample and pictures, it was verified that the c35 was damaged.The connector is broken in two sides.The membrane is not punctured, which confirms that it was not assembled with an injector.However, it seems that the connector was forced in any way and broken as a result.The breakage is not thought to be produced during manufacturing process.As the lot is unknown, retained samples and dhr cannot be reviewed.Customer complaints about the connector breakage.The connector is manufactured at bd san agustin plant but final device is assembled by atom medical.The pictures and sample received confirmed the claimed defect.It appears broken in two sides.Inspections and tests in manufacturing area: these are the inspections performed during manufacturing process for connector c35: during molding process: visual inspections for connectors are performed by the operator to avoid faulty parts (flashes, unfilled and burned parts, etc) according to ph-300 (current version).Critical to quality dimensions of all connector components are measured to check if the dimensions are within tolerance (ph-300).Luer cone and luer thread diameter are checked every 8 hours and at the beginning of the lot and after a machine stop with a go / no go gauge.Tip luer cone diameter is verified at the beginning of the lot and after a machine stop with a caliber.Assembly process: according to ph-303 it is checked the correct welding and position of the membrane, the absence of dirt and the well assembly of the cap.The correct welding of the membrane is doing according to pc-234 (current version).Finally, leakage test is performed in the quality lab to ensure the quality and functionality of the membrane according to pc-226 (current version).Investigation conclusion: the connector is broken in two sides.The membrane is not punctured, which confirms that it was not assembled with an injector.However, it seems that the connector was forced in any way and broken as a result.The breakage is not thought to be produced during manufacturing process.As the lot is unknown, retained samples and dhr cannot be reviewed.
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