Catalog Number 2420-0007 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
malfunction
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Event Description
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It was reported that bd alaris pump module smartsite infusion set was leaking the following information was received by the initial reporter with the following verbatim: rcc received a complaint via email.Email(s) attached good afternoon, i know there was a recall back in oct for item 2420-0007, we have had several incidents of leaking tubing at the lowest connection to a stationary piece before patient connection.Has this been fixed or is there another item.
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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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Manufacturer Narrative
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No product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.A device history record review for material# 2420-0007 and lot#23125382 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 18dec2023.There were no 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.
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Event Description
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No additional info.
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Search Alerts/Recalls
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