Catalog Number JC-05400-B |
Device Problem
Partial Blockage (1065)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 11/04/2015 |
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 the catheter was blocked.The issue was noted prior to use.No patient injury reported.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record (dhr) review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.The potential cause of a blocked catheter could not be determined based upon the information provided and without a sample.If the sample is returned, a follow-up report will be submitted with investigation results.
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Event Description
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The customer alleges that the catheter was blocked.The issue was noted prior to use.No patient injury reported.
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Search Alerts/Recalls
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