It was reported to covidien on (b)(6) 2016 that a customer had an issue with a salem sump tube.The customer reports that the end of the stomach tube is disconnecting from the suction connection.This is causing bile to stain and splash all over the patient, bed, and nurse.
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Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If the sample is received, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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