The customer¿s report that there was hole in the quad fuse that caused blood to back up and leak was confirmed.Visual inspection observed a lateral crack in the female luer wall of model 10015817 located at the top end of the female luer opposite of the luer gate.Residual blood was also observed throughout the set.The source of the customer¿s report of blood backing up and leaking is due to is due to the crack in the female luer component for set model 10015817.The female luer crack (for previous p/n 604467) was investigated under capa fi-2016-0010 and it was determined to be a result of internal stresses created during the manufacturing process that make it more susceptible to chemical/mechanical attacks and the materials used during molding.Previous investigations have shown that cracks may result from overtightening of the female luer on the mating components.In addition, if the luers were overtightened upon connection, then it would have been difficult to disconnect the luers from the mating components.An excess application of force may have been exerted upon disconnection, resulting in the breakage.In addition, previous similar investigations have found that if the application of alcohol was not allowed proper time to dry when connecting the mating components, it could create a bond between the two components resulting in difficulties during disconnection.Corrective action documented in trackwise capa pr 84753 dramatically reduced the internal stresses and material degradation in the luer and change order #(b)(4) was issued to document the implementation of the new female luer (p/n 630-01364).Although no lot number was provided by the customer so it is unknown if the set was manufactured prior to the implementation of corrective actions, the capa was closed as "effective" in mitigating this defect and will continue to be monitored for an increase in frequency.A device history record could not be performed due to no lot number was provided by the customer.H3 other text : see h10.
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