D4 - a partial udi was provided as the lot number is not known.The device was not returned for analysis.A corrective and preventive actions (capa) review was performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database could not be conducted because the lot number was not provided.As the device was not returned for analysis the investigation was unable to determine a conclusive cause for the reported leak difficulties.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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