Catalog Number ES-04522-BZ |
Device Problems
Failure to Advance (2524); Material Deformation (2976)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 07/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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The customer reports no progression of the guidewire in the subclavian vein, during catheter implantation.It did not progress and dented during the attempt.Patient is a newborn.Another device was inserted.
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Event Description
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The customer reports no progression of the guidewire in the subclavian vein, during catheter implantation.It did not progress and dented during the attempt.Patient is a newborn.Another device was inserted.
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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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