Model Number IPN045608 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2021 |
Event Type
Injury
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Event Description
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We had an episode of an epidural catheter shearing off upon removal on (b)(6) 2021, requiring a surgical procedure for removal.This was at vassar.The kit in use is arrow ak 05503, lot 23f21j0079.
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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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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.The customer did provide photos that appear to show a lidstock.Without the actual sample, 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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We had an episode of an epidural catheter shearing off upon removal on (b)(6) 2021, requiring a surgical procedure for removal.This was at vassar.The kit in use is arrow ak 05503, lot 23f21j0079.
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Search Alerts/Recalls
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