Catalog Number CDC-45854-XP1A |
Device Problems
Material Frayed (1262); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/13/2020 |
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 that the dilator tip was shredded after using.The reported defect was detected after use.The patient condition is reported as "fine." there was no patient complication, injury or consequence.Therapy was not delayed/interrupted.
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Event Description
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The customer reports that the dilator tip was shredded after using.The reported defect was detected after use.The patient condition is reported as "fine".There was no patient complication, injury or consequence.Therapy was not 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.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Search Alerts/Recalls
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