Model Number IPN046629 |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2021 |
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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Anesthesiologist connected the snaplock adapter onto the flextip plus catheter and could not inject medication for pain relief.Additional information: the epidural catheter was removed and replaced with a new catheter from a new epidural kit with a different lot number.The new catheter was placed and dosed without difficulty.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the epidural catheter and snaplock assembly 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 snaplock assembly 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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Anesthesiologist connected the snaplock adapter onto the flextip plus catheter and could not inject medication for pain relief.Additional information: the epidural catheter was removed and replaced with a new catheter from a new epidural kit with a different lot number.The new catheter was placed and dosed without difficulty.
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Search Alerts/Recalls
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