Catalog Number 2426-0007 |
Device Problems
Leak/Splash (1354); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/09/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Event Description
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It was reported that bd alaris pump module smartsite infusion set was damaged the following information was received by the initial reporter with the following verbatim: verbatim: the tubing was completely severed at the site right below the infusion pump cartridge.
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Event Description
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No additional information was provided.Material#: 2426-0007 lot#: 23105113 it was reported by the customer that the tubing was completely severed at the site right below the infusion pump cartridge.Verbatim: the tubing was completely severed at the site right below the infusion pump cartridge.
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Manufacturer Narrative
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It was reported by the customer that the tubing was completely severed at the site right below the infusion pump cartridge.No product or photo was returned by the customer.The customer complaint of tubing defective / damaged could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model 2426-0007 lot number 23105113 was performed.The search showed that a total of 86,403 units in 1 lot number was built on 05oct2023.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.
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Search Alerts/Recalls
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