Model Number IPN037779 |
Device Problem
Difficult to Remove (1528)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).The device has not been returned for investigation.
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Event Description
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After successful placement of epidural catheter in l4/5, upon removal of catheter, the catheter broke at the skin site with a portion of catheter remaining under the skin.After an xray it was determined that the remaining catheter would be left in the body.
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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 the root cause for this complaint investigation could not be determined based upon the information provided and without the actual 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.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.
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Event Description
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After successful placement of epidural catheter in l4/5, upon removal of catheter, the catheter broke at the skin site with a portion of catheter remaining under the skin.After an xray it was determined that the remaining catheter would be left in the body.
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Search Alerts/Recalls
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