Catalog Number JC-05400-B |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); No Information (3190)
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Event Date 05/15/2019 |
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.Teleflex will continue to monitor and trend related events.
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Event Description
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The report indicates that the user suggests that the product has been changed.Since this change they have noticed a spinal tap.The former catheter was smoother.It is noted that in 6 weeks they have had a spinal tap 12 times; lumbar puncture after confirmation that the needle was placed correctly in the epidural space.
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Manufacturer Narrative
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Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.A review of design change history for part number kz-05400-002 was performed as a part of this investigation.No design changes have been made to this part 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 with no relevant findings.The potential cause of catheter being too stiff could not be determined based upon the information provided and without a sample.
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Event Description
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The report indicates that the user suggests that the product has been changed.Since this change they have noticed a spinal tap.The former catheter was smoother.It is noted that in 6 weeks they have had a spinal tap 12 times; lumbar puncture after confirmation that the needle was placed correctly in the epidural space.
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Search Alerts/Recalls
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