Catalog Number 20350E-0006 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2023 |
Event Type
malfunction
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Event Description
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It was reported that bd alaris smartsite low sorbing extension set was occluded.The following information was received by the initial reporter with the verbatim: email received for customer informing bd of ?: faulty product as unable to prime extension set beyond filter.Customer reports that the acc dept has been using this filter set for years and it is both experienced and junior staff reporting the issues, so far nothing user error-related that they can see.Please see email for further information pir logged.
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Manufacturer Narrative
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H3.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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Manufacturer Narrative
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Investigation results: a 20350e-0006 sample was not received at the winnersh site for investigation; however the customer confirmed that the complaint sample was from lot 22119044.The customer indicates that they were unable to prime the set beyond the filter.No further information or photographs were 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 22119044 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Without a sample, it was not possible to confirm the exact root cause of the customer's experience; however, previous investigations into reports of this nature have identified that the occlusion is likely to have been caused by an excess of solvent having been applied at the tubing joint during assembly.This is a hand assembled joint and is likely to have occurred due to human.The quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 20350e-0006 set in the past 12 months.
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Event Description
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No additional information.It was reported that bd alaris smartsite low sorbing extension set was occluded.The following information was received by the initial reporter with the verbatim: email received for customer informing bd of faulty product as unable to prime extension set beyond filter.Customer reports that the acc dept has been using this filter set for years and it is both experienced and junior staff reporting the issues, so far nothing user error-related that they can see.Please see email attached for further information pir logged.
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Search Alerts/Recalls
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