Catalog Number SJ-05501 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The facility has communicated that the device is not available for investigation at this time.Teleflex will continue to monitor and trend related events.
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Event Description
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Issue reported: epidural needle was so blunt it caused severe bending as if hitting bone.
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Manufacturer Narrative
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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 needle being too blunt 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 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 being too blunt could not be determined based upon the information provided and without a sample.
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Event Description
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Issue reported: epidural needle was so blunt it caused severe bending as if hitting bone.
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Search Alerts/Recalls
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