Catalog Number SJ-05501 |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that the soft metal of the tuohy needles tips in the kits are bending easily and preventing the thread of the catheter.There was no patient injury.
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Manufacturer Narrative
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(b)(4).No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural needle with no relevant findings.A review of design change history for kit ak-05502 and part number nz-05500-001 was performed as a part of this investigation.No design changes have been made to this product in the past two years that would have led to this complaint.A corrective action is not required at this time as the potential cause of the needle tip bending could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.No lot number was provided.A device history record review was performed based upon a lot number from sales history data.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 bending during use could not be determined based upon the information provided and without a sample.
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Event Description
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It was reported that the soft metal of the tuohy needles tips in the kits are bending easily and preventing the thread of the catheter.There was no patient injury.
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Search Alerts/Recalls
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