Catalog Number AK-05502 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device is reportedly unavailable for investigation.The manufacturer will continue to monitor and trend related events.
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Event Description
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The catheter would not thread and the epidural needle was bent when it was removed.The patient's condition was reported as fine.
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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 the potential cause of the lor syringe leaking 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.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 evidence to suggest a manufacturing related cause.Therefore, the potential cause of the needle bending could not be determined based upon the information provided and without a sample.
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Event Description
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The catheter would not thread and the epidural needle was bent when it was removed.The patient's condition was reported as fine.
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Search Alerts/Recalls
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