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Model Number 19191 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Information (3190)
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Event Date 08/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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According to the complainant the device is not being returned for investigation.We are unable to confirm the reported needle mechanism failure.Lot release records were reviewed, and the product lot met all acceptance criteria.
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Event Description
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It was reported that the needle mechanism had a delayed deployment and the pod was unable to be used.The pod was discarded.
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Search Alerts/Recalls
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