Catalog Number CDC-45703-P1A |
Device Problems
Material Deformation (2976); Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/17/2020 |
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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During the procedure the wire is too thin, it is kinking.The reported defect was detected during use.The patient condition is reported as "fine".There was no patient complication, injury or consequence.It is unknown if therapy was delayed/interrupted.
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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.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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Event Description
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During the procedure the wire is too thin, it is kinking.The reported defect was detected during use.The patient condition is reported as "fine".There was no patient complication, injury or consequence.It is unknown if therapy was delayed/interrupted.
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Search Alerts/Recalls
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