Catalog Number CV-17702-E |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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Complaint received from anvisa system reports: "one day after passing the catheter, difficulty in infusing and returning blood was observed.When removing it, an internal defect was noticed, as if there were a double internal layer, reducing the lumen.".
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Event Description
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Complaint received from anvisa system reports: "one day after passing the catheter, difficulty in infusing and returning blood was observed.When removing it, an internal defect was noticed, as if there were a double internal layer, reducing the lumen.".
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Manufacturer Narrative
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(b)(4).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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