Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2203009.Medical device expiration date: 28-feb-2027.Device manufacture date: 14-mar-2022.Medical device lot #: 2204007.Medical device expiration date: 31-mar-2027.Device manufacture date: 20-apr-2022.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 28-feb-2023.H6: investigation summary twenty five samples of lot 2203009 along with twenty one sample of lot 2204007 were provided to our quality team for investigation.The products were visually inspected, no damage or defects were observed on any of the product.Drip testing was performed, the samples were connected to the appropriate luer fitting, all connections were secure, and no leakage occurred.The needle was then connected to a syringe and additional leakage testing was conducted, in all cases liquid passed from the syringe through the needle as intended and no leakage was identified.Product undergoes visual and functional testing throughout manufacturing to ensure the quality of the device, including verification that all critical dimensions are within specification.The returned samples were measured and verified all luer dimensions were within specification.A device history review was performed for lots 2203009 and 2204007, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on our investigation, a root cause related to our manufacturing process could not be identified.It was indicated the syringe used with the device was a luer slip tip.It was determined the root cause was the syringe used with the needle, a luer lock syringe is recommended to ensure proper connection of the hub as a slip tip does not properly engage with the device.
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