Initial reporter e-mail: unknown.2000e china 510k: this is an international code - the model#/catalog# identified is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is 2000e.The 510k number provided in section g5 is for the domestic similar product: k960280.Investigation summary: a 2000e china product was not available for investigation; however, the customer indicated the complaint sample was from lot 21125710.The feedback provided by the customer indicates complete occlusion was detected during use of the smartsite device.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21125710 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.Previous complaints for occlusions have been related to features on the surface of the male luer of the connecting products.These features include flash or a raised edge to the tip of the male luer which have previously been shown to intermittently lead to restricted flow due to them pinching the blue piston of the smartsite® and not allowing it to open.This can sometimes be resolved by disconnecting and reattaching the same luer connection which may reposition the luer against the piston and improve the flow, or alternatively by changing the connecting male luer.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the smartsite component in the past 12 months.
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It was reported that the bd smartsite¿ needle-free connector was found to be partially blocked during the priming process.The following information was provided by the initial reporter, translated from (b)(6): "on the morning of (b)(6) 2022, the patient was given a picc tube for dressing change, and the needle-free closed infusion connector found that the liquid was blocked.Immediately using a 20ml syringe to pass the tube was unsuccessful, and the new infusion connector was replaced later.Please can you confirm if the occlusion was identified during priming or during infusion? if during infusion, how long into the infusion? it was identified during priming.Please can you confirm the exact location of the occlusion (smartsite piston, male luer)? i cannot confirm.The user didn¿t see anything different from outside,.If possible, please can you confirm if complete occlusion was detected or slow flowrate? it was slow flowrate.".
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