The returned device sample is entering the investigation process.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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The 4f midline was returned for evaluation.Visual inspection confirmed the complaint.There is a cut in the extension line approximately 5.5 cm from the luer.The cut encircles more than ¾ the diameter of the extension line.There is an excessive amount of adhesive on the device in the area of the cut, suspected to be from the implant site dressing.When viewed under magnification, the cut appears smooth through most of the opening and only slightly jagged for a small portion of the cut.It is possible the cut was made with a sharp instrument such as scissors.Once the cut was made, the material continued to tear, causing the slightly jagged appearance to part of the tear.The device was implanted for 10 days prior to the failure.This indicates the lumen cut was not present when the device was inserted.There is no evidence of a manufacturing error.Root cause of the issue is determined to be a cut by a sharp instrument such as scissors.The instructions for use (ifu) contains the following catheter precautions: always use caution when using sharp instruments near the extension lines or catheter lumen.Do not use scissors to remove dressing.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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