We are currently waiting for additional information.It is not yet known if the device will be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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The customer returned the port, lumen, lumen lock, huber needle, and a syringe for evaluation.Visual inspection revealed no obvious defects to the port septum or lumen.A functional evaluation was performed.The lumen was clamped at the distal end and the port was flushed using the returned huber needle.While flushing a leak was noted on the top of the septum near the center.Numerous puncture marks are also visible on the septum.The root cause for the failure could not be determined.The device was forwarded to medcomp engineering for evaluation.Possible causes for a septum leak include, but are not limited to: the use of the incorrect needle type that can "core" the septum (the facility stated that only a non-coring needle was used); the needle was not fully inserted or the needle used was not long enough.If the opening of the needle was not through the septum and in the reservoir the result would be the infused solution would leak out the top of the septum.Once the septum is punctured the needle was tilted.This may damage the septum or cause fluid to leak into the subcutaneous tissue.When the port is accessed, secure the needle and extension device with a dressing.Septum integrity testing was performed to ensure that repeated access of the port with non-coring huber needles does not compromise the integrity of the port septum.The port septum was subjected to a minimum of 500 needle sticks.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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