Model Number IPN045729 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2021 |
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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Customer stating catheter is leaking medication once placed in epidural space negatively impacted patient stability and sterility.
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Event Description
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Customer stating catheter is leaking medication once placed in epidural space negatively impacted patient stability and sterility.
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Manufacturer Narrative
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Qn# (b)(4).A device history record review was performed on the epidural catheter with no relevant findings.Visual inspection could not be performed as no sample was returned for analysis.The customer did provide video that shows a leaking catheter.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual 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 with no relevant findings.The customer did provide a video that shows a leaking catheter.However, without the actual sample, the potential cause of this complaint could not be determined based upon the information provided.
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Search Alerts/Recalls
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