It was reported to covidien on (b)(6) 2016 that a customer had an issue with an umbilical vessel catheter (uvc).The customer states the uvc broke, damage at the hub site after insertion.The infant was on vent.Support, requiring uvc for blood draws and continuous blood pressure measurement.Rn notified physician, line repaired by physician without harm to patient.
|
Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the reported issue and root cause analysis.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation.The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The available information was analyzed and the potential root causes identified are defective material, machine malfunction, inspection failed or not performed, improper materials selected.At this time, a corrective or preventive action is not deemed necessary.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 performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.
|