Catalog Number CS-15282-VSP |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/20/2019 |
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 the device was inserted on (b)(6) 2018.On (b)(6) 2019 the customer indicates that a crack in the hub of the catheter was noted.Device replaced.
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Manufacturer Narrative
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(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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Event Description
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The customer reports the device was inserted on (b)(6) 2018.On (b)(6) 2019 the customer indicates that a crack in the hub of the catheter was noted.Device replaced.
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Search Alerts/Recalls
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