Catalog Number AK-05503 |
Device Problem
Break (1069)
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Patient Problem
Not Applicable (3189)
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Event Date 01/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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The epidural tray contained broken vials.There was no injury.
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Manufacturer Narrative
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Qn#(b)(4).A lot number was not 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 kit 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 provided for analysis.A device history record review was performed on the epidural kit with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the broken ampules could not be determined based upon the information provided and without a sample.
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Event Description
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The epidural tray contained broken vials.There was no injury.
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Search Alerts/Recalls
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