Catalog Number CS-14502 |
Device Problem
Unraveled Material (1664)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).Associated mdr#s 9680794-2023-00682.
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Event Description
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It was reported that "surgeon reports that it was necessary to use 3 catheters to achieve successful puncture.Two of these catheters presented bending and fraying in the guidewire, making it impossible to pass the access." the third catheter was successfully placed.The patient's condition is reported as fine.
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Event Description
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It was reported that "surgeon reports that it was necessary to use 3 catheters to achieve successful puncture.Two of these catheters presented bending and fraying in the guidewire, making it impossible to pass the access." the third catheter was successfully placed.The patient's condition is reported as fine.
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Manufacturer Narrative
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(b)(4).Associated mdr#s 9680794-2023-00681; 9680794-2023-00682.Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
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Search Alerts/Recalls
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