Catalog Number AK-05560 |
Device Problem
Break (1069)
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Patient Problem
Not Applicable (3189)
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Event Date 06/27/2016 |
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 epidural kit has a broken vial of lidocaine.There were no injuries.
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Manufacturer Narrative
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Qn#(b)(4).A device history record review was performed on the epidural kit and lidocaine 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 lidocaine ampules with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the broken ampule 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 kit has a broken vial of lidocaine.There were no injuries.
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Search Alerts/Recalls
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