SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ EXTENSION SET, LOW SORBING, 0.2 MICRON FILTER; INTRAVASCULAR ADMINISTRATION SET
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Model Number 20350ET |
Device Problem
Component Missing (2306)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported there were 2 occurrences of opening bd smartsite¿ extension set, low sorbing, 0.2 micron filter that the end cap was missing.There was no report of patient impact.The following information was provided by the initial reporter: 2 of the in-line filter opened today have no white cap attached at the end of the line.Picture shown is one of them, we have a total of 2.Name of the in-line filter is bd low sorbing extension set (0.2 micron low protein binding filter), ref (b)(4).
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Manufacturer Narrative
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The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 24-jul-2023.H.6.Investigation summary: 2 unused samples received from customer.It was reported by the customer that 2 of the in-line filter sets have no white cap attached at the end of the line.Further visual inspection of the extension set shows that the white cap was missing from the luer component and the complaint has been verified.A notification was sent to the manufacturer.After the manufacturer's investigation, it was determined that the condition of misassembly (missing component) has a root cause traced to the assembly line working outside of proper sequence at the plant.A quality alert has since been created and the responsible operators have been reinstructed on proper procedure to ensure this failure no longer occurs.A device history record review for model 20350et and lot number 21059703 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 31may2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.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 there were 2 occurrences of opening bd smartsite¿ extension set, low sorbing, 0.2 micron filter that the end cap was missing.There was no report of patient impact.The following information was provided by the initial reporter: 2 of the in-line filter opened today have no white cap attached at the end of the line.Picture shown is one of them, we have a total of 2.Name of the in-line filter is bd low sorbing extension set (0.2 micron low protein binding filter), ref (b)(4).
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Search Alerts/Recalls
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