Catalog Number CK-05401 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/01/2016 |
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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Broken vials were in the kit.There was no reported injury.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the kit and the ampules 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 on the epidural kit and ampules 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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Broken vials were in the kit.There was no reported injury.
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Search Alerts/Recalls
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