Model Number IPN918100 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2022 |
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 complaint is reported as "after 2-3 days impossibility of aspiration, flowing around the injection site.Proximal port is not working on the 4th lumen, 3 lumens were okay.".It was reported the fourth lumen was "leaky".The catheter was removed and replaced with a new 3-lumen catheter.The patient's condition is reported as fine.
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Manufacturer Narrative
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Qn#(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 complaint is reported as "after 2-3 days impossibility of aspiration, flowing around the injection site.Proximal port is not working on the 4th lumen, 3 lumens were okay.".It was reported the fourth lumen was "leaky".The catheter was removed and replaced with a new 3-lumen catheter.The patient's condition is reported as fine.
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Search Alerts/Recalls
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