It was reported to covidien on (b)(6) 2014 that a customer had an issue with a dialysis catheter.The customer reported the catheter was situated on (b)(6) 2014, and the patient was clinically stable.On (b)(6) 2014, the catheter broke spontaneously and the catheter was removed surgically.There was no harm to the patient.The exact location of the catheter breakage has not been determined at this time.
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The device history record was reviewed indicating that product was released accomplishing all quality standard requirements.There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint.The complaint sample was not returned to the manufacturing site for review.Without the sample, it is not possible to determine a confirmed root cause of this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.A corrective action is not warranted 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 nonconforming product from leaving the manufacturing operations.This information will be utilized for tracking and trending purposes to determine the need for corrective action.
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