It was reported to covidien on (b)(6) 2016 that a customer had an issue with an umbilical vessel catheter (uvc).The customer states that the catheter is folding back on itself after being inserted into the patient.The customer states they are unable to get the correct placement.After placing the line, they felt it was placed correctly, but in checking the x-ray found that it had flipped back on itself.After removing the line, the uvc did not appear to be damaged in any way and had flipped back to straight.The customer stated that the uvc had to be pulled and replaced.There was no harm or medical intervention.
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The complaint sample was not returned to the manufacturing site for review.The lot number was not provided.All device history record (dhr) are reviewed for accuracy prior to product release.Because the sample was not returned, there is not enough evidence to determine what could cause this event.The following potential causes were identified either to this document operator error, instructions for use (ifu)¿s not followed: connections, infused substances, inspection not performed adequately, material composition.However, without the sample it is not possible to determine a specific root cause for this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.There are no triggers or trends found for this event therefore no further actions are required for this investigation.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations, environmental and product biological monitoring.This complaint will be used for tracking and trending purposes.
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