Model Number IPN919630 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2023 |
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 event: yesterday we had an incident with an epidural catheter that broke an hour or so after placement.The issue was noted when the patient was not feeling relief from her epidural.Upon investigation, the epidural catheter was broken approximately two feet from the tip.The anesthesiologist repaired the tubing by cutting the end and securing a new blue cap to the end and reconnected to the infusion tubing through the epidural pump using aseptic technique.No harm to the patient occurred.The catheter was secured using tegaderm and it had been in use for 18 hours in a patient who was not ambulatory.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.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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Event Description
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Reported event: yesterday we had an incident with an epidural catheter that broke an hour or so after placement.The issue was noted when the patient was not feeling relief from her epidural.Upon investigation, the epidural catheter was broken approximately two feet from the tip.The anesthesiologist repaired the tubing by cutting the end and securing a new blue cap to the end and reconnected to the infusion tubing through the epidural pump using aseptic technique.No harm to the patient occurred.The catheter was secured using tegaderm and it had been in use for 18 hours in a patient who was not ambulatory.
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Search Alerts/Recalls
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