Catalog Number SJ-05501 |
Device Problems
Difficult to Remove (1528); Torn Material (3024)
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Patient Problem
No Information (3190)
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Event Date 08/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device is reportedly unavailable for return.The manufacturer will continue to monitor and trend related events.
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Event Description
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There was an attempt to remove the catheter from the patient.When resistance was met another clinician was brought in to assist, continual resistance was met and when the anesthesiologist attempted again, the catheter sheared.Approximately 7cm of intact catheter had to be surgically removed from the patient's epidural space.The patient's condition was reported as unknown.
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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.The ifu for this kit, e-17019-100d; rev.3, was reviewed as a part of this complaint investigation.The ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal.During epidural catheter removal, the literature indicates a force of approximately 1/3 of a pound is all that is necessary to exert if patient is properly positioned in the recommended lateral neutral position.".
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Event Description
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There was an attempt to remove the catheter from the patient.When resistance was met another clinician was brought in to assist, continual resistance was met and when the anesthesiologist attempted again, the catheter sheared.Approximately 7cm of intact catheter had to be surgically removed from the patient's epidural space.The patient's condition was reported as unknown.
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Search Alerts/Recalls
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