It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer stated that it was found that the end part of the catheter, which contains the small hole, was a little bent.The catheter could not deliver to the lowest part of the abdominal cavity.The patient had a catheter reset procedure.The catheter is still in place and the patient is stable.There was no patient injury.
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The device history record was reviewed and indicated that the product was release accomplishing all quality standards.Since the sample was not returned, there is not enough evidence to confirm what could cause this event.However the pfmea was reviewed in order to identify the possible root causes for the failure of kinking.The following potential causes were identified in the pfmea or in addition to this document: mis-execution, mishandling, extrusion machine malfunction, in-process inspection not performed, and/or defective material.With the available information it is not possible to confirm a root cause for this issue and corrective actions were not required.Should the sample be returned in the future, this complaint will be re-opened for further investigation.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.As per the procedure, manufacturing performs 100% visual inspection during production, which would identify kinks, nicks, cuts or scratches in the catheter assembly.This complaint will be used for tracking and trending purposes.
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