It was reported that 17 syringes 1ml ls sp120 had loose needle connectivity issues.The following information was provided by the initial reporter, translated from (b)(6) to english: "this is a report about syringe needle connectivity issue.The customer uses this product for covid vaccination.According to the customer's report, the connection between syringe and needle is loose and the needle is easily detached from the syringe.".
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H.6.Investigation: ten samples were provided to our quality team for investigation.The product was visually inspected, no damage, burrs, or other defects were observed within the tip of any of the syringes.A device history review was performed for the reported lot 2009096, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes visual and functional inspections throughout manufacturing, including verification of tip and thread dimensions.Testing results performed during manufacturing were reviewed lot 2009096 and all results were found to be within required limits.Ten retained samples of lot 2009096 were used for additional evaluation.The product was visually inspected, no defects or damage was observed on any of the product, including the syringe tips.Evaluations were performed on both the retained samples and product that was returned, verifying all tips were within required specifications, including the luer cone fitting.Leakage testing was also completed and all product was found to meet required limits.Based on the available information we are not able to determine a root cause related to the manufacturing process at this time.H3 other text : see h.10.
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It was reported that 17 syringes 1ml ls sp120 had loose needle connectivity issues.The following information was provided by the initial reporter, translated from japanese to english: "this is a report about syringe needle connectivity issue.The customer uses this product for covid vaccination.According to the customer's report, the connection between syringe and needle is loose and the needle is easily detached from the syringe.".
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