ARROW INTERNATIONAL INC. ARROW PI PICC KIT: 2-L 5.5FR X 50CM CG+; CATHETER, INTRAVASCULAR, THERAPEUTIC
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Model Number IPN035405 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/01/2019 |
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 customer reports that the picc line was blocked.On assessment, flushed one of the lumens, leaking from where the lumens meet the butterfly wings.
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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 customer reports that the picc line was blocked.On assessment, flushed one of the lumens, leaking from where the lumnes meet the butterfly wings.
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Search Alerts/Recalls
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