Catalog Number 930700 |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
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Event Description
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It was reported that the item was received empty.
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Manufacturer Narrative
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No samples or photos were received for analysis.A batch review was performed with the batch information provide and this was the first reported incident reported.As a result, a root cause cannot be defined and no corrective actions are required at this time.This failure mode will continue to be tracked and trended.
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Event Description
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It was reported that the item was received empty.
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Search Alerts/Recalls
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