Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the catheter shaft was found to be broken/fractured 20.5cm from the catheter hub.The catheter shaft was found to be kinked/bent 11cm from the catheter tip.There was a dried blood noted inside of the catheter hub.Functional inspection was not carried out due to the damage noted to the device.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The patient's anatomy was moderately tortuous.During the analysis the catheter shaft was seen to be broken/fractured.The catheter shaft was found to be kinked/bent.An assignable cause of procedural factors will be assigned to the as reported and as analyzed 'catheter shaft broken/fractured during use', as reported 'catheter shaft difficulty advancing', as well as the as analyzed 'catheter shaft kinked/bent', as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
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