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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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 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.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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Search Alerts/Recalls
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