H6: investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs which displayed the label of the unit indicating a 20g x 1.00in.Nexiva from lot number 2165231.The other photo shows a used nexiva unit with the clamp engaged.A portion of the extension tubing near the connection with the catheter adapter appears to be expanded resulting in an abnormally large diameter for the extension tubing.There were no tears observed on the extension tubing.The reported issue was confirmed.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.During manufacturing, a ballooned tubing (as seen on this unit) may result from an occlusion due to excess adhesive between the catheter adapter and extension tubing.During use, ballooning may occur due to a kinked, occluded, or obstructed tubing.It may also be caused by exceeding the maximum power injection pressure of 300psi.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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