Investigation summary: five picture samples were received for evaluation by our quality engineer.A device history record review was performed on the provided lot number (1806102).The review did not reveal any quality issues during the production process that could have contributed to coring.Investigation conclusion: visual inspection of the pictures revealed the presence of small particles.As the particles appeared grey in color, it is possible that they derived from the rubber stopper.Through the picture samples, an evaluation of the protector needle is not possible.Root cause description: coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.Based on the investigation results, a definite cause for this incident could not be determined.Rationale: use of the m12 assembly fixture is recommended to reduce coring tendency and ensure proper connection of the device.A corrective action and preventive action plan has been initiated to further investigate this issue.Complaints received for this device and defect will be closely monitored by our quality team.
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