Catalog Number AK-05502 |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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The report states: they recently had some issues again with the catheters not advancing through the needle.
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Event Description
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The report states: they recently had some issues again with the catheters not advancing through the needle.
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Manufacturer Narrative
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Qn#(b)(4).The lot number provided by the customer is not a valid lot number for this kit number.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 catheter and needle with no relevant findings.A review of design change history for kit ak-05501, part number nz-05500-001, and kz-05400-030 was performed as a part of this inves tigation.No design changes have been made to this product in the past two years that would have led to this complaint.Complaint verification testing could not be performed as no sample was returned for analysis.The lot number provided by the customer is not a valid lot number for this kit number.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 catheter and needle with no relevant findings.The potential cause of catheter not advancing could not be determined based upon the information provided and without a sample.
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Event Description
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The report states: they recently had some issues again with the catheters not advancing through the needle.
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Manufacturer Narrative
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(b)(4).Lot# updated to 23f20b0039: a device history record review was performed on the epidural catheter and needle with no relevant findings.A review of design change history for kit ak-05501, part number nz-05500-001, and kz-05400-030 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 a potential root cause 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.A device history record review was performed on the epidural catheter and needle with no relevant findings.The potential cause of catheter not advancing could not be determined based upon the information provided and without a sample.
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Search Alerts/Recalls
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