The device was returned for analysis.The reported leak was unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.As the reported leak was unable to be confirmed during return analysis, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the connection port was not fully connected/tightened and/or the device being connect to was compromised; thus resulting in the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|