Catalog Number 20350E |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd alaris¿ smartsite¿ low sorbing extension set had a flimsy kinked area.The following information was provided by the initial reporter: fluid would not flow through filter.On (b)(6) 2023, tpn filter tubing had a kinked area flimsier than the rest of the tubing; appeared discolored/cloudy.
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Manufacturer Narrative
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H6: investigation summary: no product or photo was returned by the customer.The customer complaint that fluid would not flow through filter could not be verified due to the product not being returned for failure investigation.A device history record review for model 20350e lot number 22099098 was performed.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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It was reported that the bd alaris¿ smartsite¿ low sorbing extension set had a flimsy kinked area.The following information was provided by the initial reporter: fluid would not flow through filter.1/18/2023 tpn filter tubing had a kinked area flimsier than the rest of the tubing; appeared discolored/cloudy.
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Search Alerts/Recalls
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