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Model Number 19191 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/23/2023 |
Event Type
malfunction
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Event Description
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It was reported by the patient that they activated a pod but after wearing it the cannula came out.The cannula was not visible when the pod was removed but confirmed that the cannula was inserted.
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Manufacturer Narrative
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According to the complainant the device will not be returned for investigation.We are unable to confirm the reported needle mechanism failure or to determine its root cause.Lot release records were reviewed and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including confirming that the device deployed the cannula correctly.
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Search Alerts/Recalls
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