IRVINE BIOMEDICAL, INC. COOL POINT TUBING SET; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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Lot Number H17242412 |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/17/2020 |
Event Type
No Answer Provided
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Event Description
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Upon spiking heparinized saline flush bag to prime tubing, product found to have crack in tubing, creating an area where fluid would leak.Fda safety report id# (b)(4).
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