Catalog Number SJ-05501 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(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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Anesthesia tech notified me that multiple crnas and mds have experienced issues with catheter not threading through needle once epidural space has been located requiring resticking.
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Event Description
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Anesthesia tech notified me that multiple crnas and mds have experienced issues with catheter not threading through needle once epidural space has been located requiring resticking.
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Manufacturer Narrative
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Qn#(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 catheter and needle with no relevant findings.A design history review was performed for part # kz-05500-007 and kz-005400-030 as a part of this complaint investigation.There have been no material changes for these parts during the last two years that could 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.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 catheter and needle with no relevant findings.The potential cause of this complaint could not be determined based upon the information provided and without the sample.No further action is required at this time.
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Search Alerts/Recalls
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