Catalog Number FR-05501-10 |
Device Problem
Failure to Advance (2524)
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Patient Problems
Pain (1994); No Consequences Or Impact To Patient (2199)
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Event Date 01/13/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device sample was not returned for evaluation at the time of this report.
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Event Description
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The customer alleges that the catheter was difficult to insert inside the needle.The catheter would not fit.The alleged issue delayed the procedure and the patient was in pain.
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Manufacturer Narrative
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Qn#(b)(4).The customer returned one sealed kit from the same lot number for evaluation.The kit was opened and the epidural needle and epidural catheter were removed.The components were visually examined and no defects or anomalies were observed.A dimensional inspection was performed on the returned epidural needle and it was found to be within specification.Functional testing was also performed and there were no issues found.A device history record (dhr) review was performed on the epidural needle and epidural catheter with no relevant findings.The reported complaint of difficulty threading the epidural catheter through the needle could not be confirmed based on the sample received.The actual complaint sample was not returned; only a representative sample was received.The returned epidural catheter could be threaded through the returned needle with no resistance met.The returned components passed a functional drag test, and the returned needle id and returned catheter od were found to be within specification.A dhr review was performed on the epidural needle and catheter with no evidence to suggest a manufacturing related cause.A potential root cause could not be determined based upon the information provided or without the actual complaint sample.
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Event Description
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The customer alleges that the catheter was difficult to insert inside the needle.The catheter would not fit.The alleged issue delayed the procedure and the patient was in pain.
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Search Alerts/Recalls
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