Model Number IPN040048 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2021 |
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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Epidural catheterization kit broke mid procedure.Customer was doing a caudal epidural and in the last part of the procedure the customer noticed a failure in the wall of the catheter specifically.The contrast showed ballooning of the wall.The customer was able to retrieve the catheter with no adverse outcome to the patient that they are aware of.On further inspection of the catheter post-procedure they noticed a longitudinal tear in the wall of the catheter.Due to severity of the issue, the customer is requesting immediate follow-up.
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Event Description
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Epidural catheterization kit broke mid procedure.Customer was doing a caudal epidural and in the last part of the procedure the customer noticed a failure in the wall of the catheter specifically.The contrast showed ballooning of the wall.The customer was able to retrieve the catheter with no adverse outcome to the patient that they are aware of.On further inspection of the catheter post-procedure they noticed a longitudinal tear in the wall of the catheter.Due to severity of the issue, the customer is requesting immediate follow-up.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.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 evidence to indicate a manufacturing related issue.The customer did provide a photo that appears to show an epidural catheter tip.However, without the actual sample, the potential cause of this complaint could not be determined based upon the information provided.No further action is required at this time.
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Search Alerts/Recalls
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