Catalog Number MAXL181 |
Device Problem
Material Deformation (2976)
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Patient Problem
Headache (1880)
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Event Date 06/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Four unopened sets of portex® epidural maxipack were provided for analysis in which the tuohy needle was included.The used sample was not provided.The customer's reported problem was "patient injury due to a burr in the area of the tip of the tuohy needle".The four included touhy needles were visually inspected, but no deviations were found.The tuohy needle tip was visually inspected under a microscope.No burr or deviation was detected on all 4 samples.In the device history record (dhr), there is no hint of such a failure.The quality inspection processes were reviewed and considered adequate and correct.Investigation was unable to confirm the customer's reported problem.
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Event Description
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It was reported that there was a patient injury due to a burr in the area of the tip of the tuohy needle from a portex® epidural maxipack.The alleged injury to the dura mater spinalis and thus necessary blood patch due to cerebrospinal fluid (csf) leak.The patient complained post-op about headaches.No other patient injury was reported.
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Manufacturer Narrative
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Four unopened portex® epidural maxipack kits were returned, which contain tuohy needle (b)(4), for analysis.No deviations were noted upon visual exam.A microscope was used to further investigate the tuohy needle tip; no deviations detected.Based on the evidence, the complaint was not confirmed as no fault was found.
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Search Alerts/Recalls
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