Root cause: the device is manufactured for (b)(4) by (b)(4).A photograph of the defective device was sent to (b)(4) for evaluation, and the manufacturer determined that the root cause was the result of use error.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary: an internal complaint (b)(4) was received for a foley catheter (finished good 81-080408, lot not provided) that contained a temperature probe wire that was protruding from the device.The device history record could not be reviewed because the lot number was not reported.Raw material and finished good inventory were checked and no non-conforming product was found.A sample was received from the customer for evaluation.Photos of the defective device were taken and sent to the manufacturer, (b)(4), for evaluation.The vendor determined that the catheter was pulled strongly, stretching the silicone shaft and thermocouple wire, which caused the deformation.A supplier corrective action request was issued to (b)(4).A response has been received.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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