Catalog Number SA-15853 |
Device Problem
Material Frayed (1262)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The product (catalog# sa-15853) is not sold in the us.Similar product sold in the us.
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Event Description
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Customer reported that the dilator trumpeted once the inserter had the swg (spring wire guide) through the needle.This was a left subclavian vein placement.
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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.
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Event Description
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Customer reported that the dilator trumpeted once the inserter had the swg (spring wire guide) through the needle.This was a left subclavian vein placement.
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Search Alerts/Recalls
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