Catalog Number EC-05500 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/04/2019 |
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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It was reported that the md felt that the catheter was softer than usual and had difficulty in placement of the catheter at the 2 operations; he/she had to insert and pull out the catheter several times for placement.There was no problem on the other 4 catheters that the md placed on different days.
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Event Description
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It was reported that the md felt that the catheter was softer than usual and had difficulty in placement of the catheter at the 2 operations; he/she had to insert and pull out the catheter several times for placement.There was no problem on the other 4 catheters that the md placed on different days.
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Manufacturer Narrative
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(b)(4).A lot number was not 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 catheter with no relevant findings.A review of design change history for part number kz-05400-002 was performed as a part of this investigation.No design changes have been made to this part 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 lot number was not 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 catheter with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of the catheter being too soft could not be determined based upon the information provided and without a sample.
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Search Alerts/Recalls
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