Catalog Number ASK-05560-WH |
Device Problems
Knotted (1340); Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/17/2016 |
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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The flex tip catheter knotted in the patient during removal.The catheter was able to be completely removed without patient injury.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 based upon a lot number from sales history data and was performed on the epidural catheter with no relevant findings.The ifu for this product, e-25090-100a; rev.02, was reviewed as a part of this complaint investigation.The ifu warns the end user, "never advance catheter more than 5 cm.Advancing catheter more than 5 cm increases the likelihood of catheter tip being placed into anterolateral portion of the epidural space and increases potential for catheter knotting.Never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage." 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 provided 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.Therefore, the potential cause of the catheter knotting in the patient could not be determined based upon the information provided and without the sample.
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Event Description
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The flex tip catheter knotted in the patient during removal.The catheter was able to be completely removed without patient injury.The patient's condition was reported as fine.
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Search Alerts/Recalls
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