Model Number 6DIC |
Device Problem
Contamination of Device Ingredient or Reagent (2901)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during routine inner cannula change, an extra plastic was noted beneath the wing on one side of the cannula.The customer reported that there was no patient involvement.
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Manufacturer Narrative
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Evaluation summary: one sample of disposable inner cannula was received for evaluation.A visual inspection was performed and it was observed the cannula present a piece of plastic attached under the connector snap, the failure mode flash is confirmed.The investigation could not determine a cause of the event.The product relates to the reported complaint event.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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