Catalog Number CV-15123-F |
Device Problem
Material Deformation (2976)
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Patient Problem
Hematoma (1884)
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Event Date 02/14/2020 |
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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The customer reports: catheter presented a problem in the guide wire, which folds inside the vessel, causing hematoma in the patient.It was necessary to open another common cvc to use the guide wire.
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Event Description
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The customer reports: catheter presented a problem in the guide wire, which folds inside the vessel, causing hematoma in the patient.It was necessary to open another common cvc to use the guide wire.
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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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