Catalog Number FR-05501-10 |
Device Problem
Failure to Advance (2524)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 01/09/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).It is unknown if the device sample is available for evaluation.
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Event Description
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The customer alleges that it was impossible to introduce the catheter inside the needle; the catheter was stuck at the entrance of the needle.
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Manufacturer Narrative
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(b)(4) the customer returned one epidural catheter, one epidural needle with stylet, and one flat filter.The returned components were visually examined and no defects were observed.A dimensional inspection was performed on the returned epidural needle and catheter and they were found to be within specification.Functional testing was also performed and no issues were 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 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 inner diameter and returned catheter outer diameter were found to be within specification.A dhr review was performed on the epidural needle and catheter with no relevant findings.
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Event Description
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The customer alleges that it was impossible to introduce the catheter inside the needle; the catheter was stuck at the entrance of the needle.
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Search Alerts/Recalls
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