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.
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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.Two unused samples were received for the evaluation.Based on the procedure, a visual inspection was conducted on the received samples.Upon evaluation, the reported issue was not observed.In addition, a pull test was performed to the received samples, and the test meet the quality specifications.However, there have been complaints reported in the past for catheter detachment.As part of continuous improvements, a corrective action (capa) has been opened to address the reported issue.The results of investigation will be documented through the referred capa.
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