Catalog Number AI-07155-IK |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This complaint is linked to mdr no.1036844-2020-00074 and teleflex complaint no.(b)(4).
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Event Description
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It was reported that the temporary trans-venous pacing (tvp) was inserted serosanguinous backflow was noted in the sterile sheath.The site continued to leak despite ensuring all connection were tight and secure.When removing the old luer lock valve from the old set up, the rubber stopper was popped out of the plastic casing (the valve was not intact).As a result, a new catheter was used.There was no report of patient complications, serious injury or death.
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Event Description
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It was reported that the temporary trans-venous pacing (tvp) was inserted serosanguinous backflow was noted in the sterile sheath.The site continued to leak despite ensuring all connection were tight and secure.When removing the old luer lock valve from the old set up, the rubber stopper was popped out of the plastic casing (the valve was not intact).As a result, a new catheter was used.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn#(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of sheath valve leak is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.Other remarks: this complaint is linked to mdr no.1036844-2020-00074 and teleflex complaint no.(b)(4).
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Search Alerts/Recalls
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