Catalog Number ASK-05401-NM |
Device Problem
Failure to Align (2522)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/09/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
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Event Description
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The stylet lines up with the hub but does not go all the way.There was no patient harm.
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Manufacturer Narrative
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(b)(4).No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural needle with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural needle with no evidence to indicate a manufacturing related cause.Therefore, the potential cause of the stylet hub not engaging with the needle hub could not be determined based upon the information provided and without a sample.
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Event Description
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The stylet lines up with the hub but does not go all the way.There was no patient harm.
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Search Alerts/Recalls
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