An investigation was performed for the reported customer complaint: ¿the customer reports the unit is leaking just below the hub where the catheter is joined." no lot number was provided.A review of the device history report (dhr) was unable to be performed.However, all dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.Will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|