Model Number 2000E |
Device Problems
Complete Blockage (1094); Restricted Flow rate (1248)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported ll vlv adpt(stand alone) was blocked.The following information was provided by the initial reporter, translated from chinese: "check before use and find blockage".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-11-16.H6: investigation summary eighteen 2000e china samples were received for investigation, nine in opened packaging from lot 21045802 and nine were received without packaging.No connecting products were received to assist the investigation in this instance.Functional testing was performed by connecting a 50ml bd plastipak syringe to the received samples; it was observed for all of the returned samples, the piston of the smartsite opened and no occlusion was observed.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21045803 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Following a small number of similar reports, bd has conducted an in-depth investigation to identify any potential contributing factors for occlusion of this nature.Capa 1998036 has been initiated.The investigation has determined that a potential contributor could be the result of an insufficient amount of fluorosilicone having been injected into the piston of the smartsite during the assembly process; fluorosilicone is used as a lubricant within the smartsite to ensure the consistent opening of the piston when the smartsite is activated, and an insufficient amount may cause a temporary occlusion.Additionally previous investigations have also determined that features on the surface of the male luer of the connecting products may also contribute to occlusions of this nature.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.In this instance as the connecting product was not available for investigation it could not be determined which is the most likely root cause for the customer's experience in this instance.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 2000e china product in the past 12 months.
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Event Description
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It was reported ll vlv adpt(stand alone) was blocked.The following information was provided by the initial reporter, translated from chinese: "check before use and find blockage".
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Event Description
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It was reported ll vlv adpt(stand alone) was blocked.The following information was provided by the initial reporter, translated from chinese: "check before use and find blockage".
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Manufacturer Narrative
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H6: investigation summary a 2000e china sample was not available for investigation; however the customer confirmed that the complaint sample was from lot 21045803.The connecting product in use at the time of the customer's experience was not returned to assist the investigation.Further information provided by the customer indicates that an occlusion was observed during priming of the smartsite using a wei gao syringe.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21045803 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.Following a small number of similar reports, bd has conducted an in-depth investigation to identify any potential contributing factors for occlusion of this nature.Capa 1998036 has been initiated.The investigation has determined that a potential contributor could be the result of an insufficient amount of fluorosilicone having been injected into the piston of the smartsite during the assembly process; fluorosilicone is used as a lubricant within the smartsite to ensure the consistent opening of the piston when the smartsite is activated, and an insufficient amount may cause a temporary occlusion.Additionally previous investigations have also determined that features on the surface of the male luer of the connecting products may also contribute to occlusions of this nature.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.In this instance as the connecting product and affected product were not available for investigation it could not be determined which is the most likely root cause for the customer's experience in this instance.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 2000e china product in the past 12 months.
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Search Alerts/Recalls
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