Model Number IPN919609 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2023 |
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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Reported issue: the spinal needle was removed, and the epidural catheter was attempted to be threaded.It would not advance beyond the tip of the needle.After multiple efforts to thread the catheter the catheter gave a pop sensation, and then threaded.The catheter felt snug in the tuohy needle when the tuohy needle was removed.A close-up photograph of the tip of the epidural needle was taken and there is a lip of metal that is at the tip of the needle orifice facing inward.This is where the catheter was catching on in our attempt to advance the catheter.
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Event Description
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Reported issue: the spinal needle was removed, and the epidural catheter was attempted to be threaded.It would not advance beyond the tip of the needle.After multiple efforts to thread the catheter the catheter gave a pop sensation, and then threaded.The catheter felt snug in the tuohy needle when the tuohy needle was removed.A close-up photograph of the tip of the epidural needle was taken and there is a lip of metal that is at the tip of the needle orifice facing inward.This is where the catheter was catching on in our attempt to advance the catheter.
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Manufacturer Narrative
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Qn# (b)(4).The actual device was not returned; however, the customer did provide a photo that appears to show a bent tip on an epidural needle.A device history record review was performed on the epidural catheter and epidural needle with no relevant findings.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Search Alerts/Recalls
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