Catalog Number AK-00376 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250); Suction Problem (2170)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/17/2020 |
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 doctor performed a bedside thoracentesis.Upon inserting 8fr catheter with 3 way stopcock, blood/pleural fluid was leaking from a crack in hub of catheter.This leak prevented adequate suction for procedure to be performed effectively and efficiently.
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Manufacturer Narrative
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Qn#(b)(4).The customer returned one paracentesis kit lidstock for evaluation.Visual inspections of the stopcock could not be performed as no stopcock was returned.A device history record review was performed and no relevant findings were identified.The instructions-for-use provided with this kit instructs the user, "attach male luer end of syringe tubing (included) to stopcock side port on catheter device.Ensure that the drainage outlet located at the bottom of the bag is in the closed position.Insert large connector firmly into drainage bag.Turn stopcock handle toward valve to open side port.Fluid can now be removed by gently moving syringe piston in and out, in a pumping motion." the customer report of stopcock leaking during use could not be confirmed by complaint investigation because the stopcock was not returned.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.The root cause could not be determined without the stopcock.Teleflex will continue to monitor and trend for complaints of this nature.
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Event Description
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The doctor performed a bedside thoracentesis.Upon inserting 8fr catheter with 3 way stopcock, blood/pleural fluid was leaking from a crack in hub of catheter.This leak prevented adequate suction for procedure to be performed effectively and efficiently.
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Search Alerts/Recalls
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