Catalog Number AK-04550-S |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
Tissue Damage (2104)
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Event Date 05/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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Physicians complain that the vessel dilator has a blunt square tip.In one instance, during line insertion into a radial artery the vessel dilator proved to be too blunt and has caused a number of dissections as reported by physicians.Due to this the patient received radial artery damage.The patient condition is reported as fine and healing normal.
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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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Physicians complain that the vessel dilator has a blunt square tip.In one instance, during line insertion into a radial artery the vessel dilator proved to be too blunt and has caused a number of dissections as reported by physicians.Due to this the patient received radial artery damage.The patient condition is reported as fine and healing normal.
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Search Alerts/Recalls
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