Model Number IPN923947 |
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 05/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Medwatch report 5118021.
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Event Description
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It was reported via medwatch that "the rn exerted higher than normal traction when removing the epidural catheter causing it to snap.Per discussion with the rn involved, the catheter fell out as she was removing the dressing tape.Anesthesiologist believes the tip of the epidural catheter remains in the patient; x-ray confirmed no radiopaque foreign body present".Additional information received states that "a ct scan was not done as the patient had already discharged.X-ray confirmed no radiopaque foreign object present.No medical intervention done, but the anesthesiologist did speak with the patient for possible retention of a foreign body".No report of patient harm or injury.
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Event Description
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It was reported via medwatch that "the rn exerted higher than normal traction when removing the epidural catheter causing it to snap.Per discussion with the rn involved, the catheter fell out as she was removing the dressing tape.Anesthesiologist believes the tip of the epidural catheter remains in the patient; x-ray confirmed no radiopaque foreign body present".Additional information received states that "a ct scan was not done as the patient had already discharged.X-ray confirmed no radiopaque foreign object present.No medical intervention done, but the anesthesiologist did speak with the patient for possible retention of a foreign body".No report of patient harm or injury.
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Manufacturer Narrative
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Qn#(b)(4).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 evidence to suggest 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 was required at the time of the report.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Search Alerts/Recalls
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