It was reported to covidien on (b)(6) 2016 that a customer had an issue with an umbilical vessel catheter (uvc).The customer reports when they remove the cap (another company provides the caps) that attach onto the uvc (every 24 hours), blood will leak out as they do not have a way to secure the uvc line.Because they do not have a way to close off the port when the cap is removed, they are bending/folding the uvc just below the hub where the catheter is joined and securing it down with a transparent dressing.After they do this, the line seems to crack and leak.
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Submit date: 11/16/2016.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was received for evaluation.An underwater test was performed and a leak was found below the strain relief.Under magnification, a cut was found below the strain relief.Based on the appearance of the sample, it is possible that the catheter was damaged by instruments with sharp or rough edges during clinical use, resulting in a catheter leak.As per the instructions for use, exercise caution when using sharp instruments near the catheter.Do not use instruments with sharp or rough edges directly on the catheter since even a minor cut could tear or break the catheter.Do not pinch or bend the catheter back to temporarily occlude the catheter.This causes increased stress on the catheter which can lead to a leak or break.Do not use alcohol, acetone, or alcohol containing antiseptics directly on the catheter.Carefully check antiseptic solutions for alcohol or acetone.These substances may cause irreversible damage to the polyurethane which can lead to a leak or break.Ensure gloves or other surfaces which have alcohol on them are completely dry before touching or manipulating the catheter.There are a number of alternatives on the field like exposure to chemical agents, proximity to heat sources, or manipulation that may lead to tubing tear.A corrective or preventive action is not deemed necessary at this time.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent non-conforming product from leaving the manufacturing operations.
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