Catalog Number AK-05560 |
Device Problems
Break (1069); Unraveled Material (1664)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
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Event Description
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An epidural catheter was placed into laboring patient without issues but it was difficult to remove at the end.The internal wire broke or unraveled at approximately the 9cm mark when removal was attempted.The catheter was surgically removed.The patient's condition was reported as fine.
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Manufacturer Narrative
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(b)(4).No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit, (b)(4); rev.7, 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." 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.No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the catheter with no evidence to suggest a manufacturing related cause.The potential cause of the catheter breaking during removal could not be determined based upon the information provided and without a sample.
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Event Description
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An epidural catheter was placed into laboring patient without issues but it was difficult to remove at the end.The internal wire broke or unraveled at approximately the 9cm mark when removal was attempted.The catheter was surgically removed.The patient's condition was reported as fine.
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Search Alerts/Recalls
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