SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MALE/FEM LUER-LOCK CAPS; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 70804 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The customer's address is unknown.Unknown, (b)(6) has been used as a default.Investigation summary: a complaint of particulates being found on the set prior to use was received from the customer.No product or photo was returned by the customer.The customer complaint of foreign matter could not be verified due to the product not being returned for failure investigation.A device history record review for model and lot number was performed.There was 1 quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported male/fem luer-lock caps had foreign matter.The following information was provided by the initial reporter: "cap luer lock male/female 70804 20107040 particulate 1.".
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Search Alerts/Recalls
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