Catalog Number UI-05502 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Information (3190)
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Event Date 06/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that there is difficulty with passing the catheter out the end of the tuohy.One patient's dura was punctured unintentionally with this product.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.A review of design change history for kit ui-05502, part number nz-05500-001, and kz-05400-002 was performed as a part of this investigation.No design changes have been made to this product in the past two years that would have led to this complaint.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 catheter and needle with no relevant findings.The potential cause of catheter not threading could not be determined based upon the information provided and without a sample.
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Event Description
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It was reported that there is difficulty with passing the catheter out the end of the tuohy.One patient's dura was punctured unintentionally with this product.
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Search Alerts/Recalls
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