Catalog Number CS-24703-E |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2024 |
Event Type
malfunction
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Event Description
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It was reported "dilator damaged during insertion, it was found that the dilator was deformed and the swg could not be entered smoothly." they changed to a new set.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported "dilator damaged during insertion, it was found that the dilator was deformed and the swg could not be entered smoothly." they changed to a new set.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
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Manufacturer Narrative
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Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Search Alerts/Recalls
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