Catalog Number MP-17019-TKL |
Device Problem
Bent (1059)
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Patient Problem
No Information (3190)
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Event Date 06/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device investigation report has not been submitted at this time.The manufacturer will continue to monitor and trend related events.
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Event Description
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While performing a labor epidural placement the toughy needle tip folded over.The patient's condition was reported as unknown.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the epidural needle with no relevant findings.The customer reported the epidural needle tip folded during use.The customer returned two sealed kits for evaluation (reference files (b)(4)).No actual complaint sample was received.The epidural needle from both sealed kits was visually examined with and without magnification.Visual examination of both returned needles revealed that the needles appeared typical with no observed defects or anomalies.The needle bevel appears typical for both needles.No burrs or deformations were observed.The needle stylet fills the bevel appropriately.The needle cannula is smooth (reference files (b)(4)).An attempt was made to bend the needle by pressing the needle tip against a hard metal surface.The needle bevel did bend slightly but the tip did not fold.However, great pressure was applied.The same test was performed on a lab inventory epidural needle of the same kind with similar results.The same test was performed on the second needle with similar results as well.Other remarks: a corrective action is not required at this time as the potential root cause could not be determined based upon the information provided and without the actual complaint sample.Complaint verification testing could not be performed as the actual complaint sample was not returned for analysis.The customer returned two sealed kits only.The epidural needle from each sealed kit appeared typical with no observed defects.An attempt was made to bend the returned needles by pressing the needle bevel against a hard surface.However, the returned needles resulted in similar results to a lab inventory needle of the same kind.A device history record review was performed on the epidural needle with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the needle tip folding during use could not be determined based upon the information provided and without the actual complaint sample.
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Event Description
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While performing a labor epidural placement, the toughy needle tip folded over.The patient's condition was reported as unknown.
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Search Alerts/Recalls
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