The failed sample will be returned to vygon for device evaluation as part of the complaint investigation.
The results of this investigation are still pending,and will be communicated to fda within 30 days of its conclusion.
The batch review does not shown any non-conformity.
The products are in conformity with the specifications.
The device is compliant to norm iso (b)(4).
The tightness and the rounded tip of each umbilical catheter are controlled.
There is no other complaint on this batch and no similar complaint on this product reference.
Extravasation could be a complication due to a vessel perforation or a weakness of the vessel wall.
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