Model Number 20159E |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 22029775.Medical device expiration date: 17-feb-2025.Device manufacture date: 17-feb-2022.Medical device lot #: 21119807.Medical device expiration date: 05-nov-2024.Device manufacture date: 05-nov2021.Medical device lot #: 22039080.Medical device expiration date: 04-mar-2025.Device manufacture date: 04-mar-2022.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Event Description
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It was reported that 5 bd alaris smartsite extension sets from lot 22039080, 1 set from lot 21119807, and 3 sets from lot 22029775 experienced flow issues.The following information was provided by the initial reporter: customer stated the device is not letting fluid flow properly.
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Manufacturer Narrative
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H.6.Investigation summary: three samples (model #20159e), nine samples (model #20159e), and five samples (model #20159e) were returned by the customer.It was reported that the device is not letting fluid flow properly.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The samples were connected to a cut off syringe tip to check that the fluid path is in an activated position/open when connected to a syringe.The samples were then attempted to be flushed with water using a 10ml bd syringe to confirm an open fluid path.The fluid paths of two samples were open and those samples were able to be flushed.The failure was unable to be replicated in these samples.The fluid path of one sample was not open and was unable to be flushed.The customer complaint can be verified in this sample.A root cause was unable to be determined.Due to an increase in incidents of this failure mode, a trend for this occlusion issue has been identified for this product line, a capa (corrective action preventative action) has been initiated, and a team has been assembled in order to investigate the issue.A device history record review for model 20159e lot number 22039080 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 20159e lot number 21119807 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 08nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 20159e lot number 22029775 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 22feb2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
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Event Description
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It was reported that 5 bd alaris smartsite extension sets from lot 22039080, 1 set from lot 21119807, and 3 sets from lot 22029775 experienced flow issues.The following information was provided by the initial reporter: customer stated the device is not letting fluid flow properly.
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Search Alerts/Recalls
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