This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.A picture and six used samples were received for evaluation.No damage was observed in the picture.The returned samples were inspected under normal illumination finding that two of the six units were separated from the connector and the wire was exposed.Additionally, the adhesive was attached to the connector.The the reported failure was confirmed.There is 100 percent inspection of all parts during assembly and a sampling of finished products for defects.Therefore, the most likely root cause of the report product problem was damage that occurred after the device left the manufacturing facility.Preventive actions taken for mitigation of the reported issue was production personnel were notified of the defect.Additionally, instructions for use instructs the user on proper handling of the device.(udi / catalog) and (510k) are unknown.No product information has been provided to date.
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