The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
|
A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of the reported issue.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.The quality inspection of final visual and physical evaluation results indicated that the product met specification requirements for release.One unused catheter from lot number 1905700096 was received inside of a plastic bag with its original package opened.In order to confirm the condition reported, red ink was used to flush the sample and the test showed that the ink did not pass through the extensions.Additional testing was performed in order to confirm the location of the occlusion; the extensions were cut and using a pin gage of 0.008¿ in both extensions the pin gage passed without any problem; then, the catheter was cut below the junction and the pin gage would not pass through the y junction.Based on this test is was determined that the occlusion is located at the ¿y¿ junction.The occlusion was created by an air pressure chamber not allowing the fluids to enter.The reported condition was confirmed.The observed rate of occurrence and the observed severity of harm are lower than to that which is expected.Therefore, a formal corrective/preventative action (capa) was opened to address this issue and corrective or preventive actions will be taken within this capa.Additionally, no trends or triggers have been found.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.
|