The device involved in the incident was not returned for evaluation.A video provided by the customer shows ballooning of the venous extension immediately below the over-molded protective sleeve while flushing the catheter.The video was sent to contract manufacturer and a review of the manufacture records was requested.A follow up report will be submitted when the investigation is complete.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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