Model Number IPN923217 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2022 |
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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Just wanted to let you know we were unable to pull the stylet out of the catheter again and ended up getting the stylet out of the needle but tore the catheter in the process.No patient harm noted.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the epidural catheter and stylet 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 and stylet with no evidence to indicate a manufacturing related issue.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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Just wanted to let you know we were unable to pull the stylet out of the catheter again and ended up getting the stylet out of the needle but tore the catheter in the process.No patient harm noted.
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Search Alerts/Recalls
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