Catalog Number 2C8541 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2024 |
Event Type
malfunction
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Event Description
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It was reported that tubing of a clearlink duo-vent continu-flo solution set separated from the drip chamber.This occurred prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph observed a separation between the assembly of the tubing and the drip chamber.The reported condition was verified.The cause of the condition is related to manufacturing.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction to b3 (incorrect date).Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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