Catalog Number AK-05501 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/31/2017 |
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 evaluation.The manufacturer will continue to monitor and trend related events.
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Event Description
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The touhy needle tip crimps over as it hits bone or hard cartilage preventing passage of the catheter.The patient's condition was reported as fine.
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Manufacturer Narrative
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(b)(4).A device history record review was performed based upon a lot numbers provided by the customer.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 tip bending 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 numbers provided by the customer.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 touhy needle tip crimps over as it hits bone or hard cartilage preventing passage of the catheter.The patient's condition was reported as fine.
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Search Alerts/Recalls
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