Upon completion of the investigation it was noted that the position of the cam when valve was received was at setting 2.The valve was visually inspected; it was noted that the needle base was slight raised, as well as needle holes in the needle chamber.The valve was hydrated.The valve was tested for programming.The valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested.Leaked from the needle holes in the needle chamber.The valve was reflux tested.The valve passed the test.The siphon guard was tested.The valve passed the test.The valve was dried.The siphon guard was removed.The valve was then pressure tested, the valve passed the test.Review of the history device records was not possible as the lot number is unknown.No functional problem was noted with the valve.The root cause for the slightly raised needle guard base, was probably due to user error, as noted in the ifu: (do not fold or bend the valve during insertion.Folding or bending might cause rupture of the silicone housing, needle guard dislodgement, or occlusion of the fluid pathway.), this however could not be determined.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
|