Catalog Number 2426-0007 |
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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Manufacturer Narrative
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B3.The date received by manufacturer has been used for this field.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 leaking the following information was received by the initial reporter with the following verbatim: one of our clinics filed a product complaint with our department regarding the becton dickinson mfg # 2426-0007, saying that they were experiencing leakage at the y-site connector.The description of the even was as follows: ¿bd alaris pump infusion set leaking at the y-site connector.Ref # 2426-0007 lot # 24015455.This occurred when infusion rate was set to 25ml/hr running normal saline.¿.
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Manufacturer Narrative
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No product or photo was returned by the customer.The customer complaint that there was a leak could not be verified due to the product not being returned for failure investigation.A device history record review for model 2426-0007 lot number 24015455 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 20jan2024.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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