Submit date: 4/25/2016.The device history record file was reviewed indicating that product was released accomplishing all quality standard requirements.There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint.A sample was received for evaluation.After performing a visual inspection per procedure, the blue connector was found detached.The most likely root cause for the reported condition is lack of solvent.The solvent was dispensed inconsistently on the area where tube connects with the connector.This is due to an occluded solvent injection.The production personnel were notified of the reported issue.A quality alert was posted and functional stress tests will be conducted hourly by production.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.
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