ICU MEDICAL, INC. ICU MEDICAL 131" SINGLE LEAD TRANSFER SET W/CLAMP, LUER LOCK; STOPCOCK, I.V. SET
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Lot Number 5065292 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/09/2021 |
Event Type
malfunction
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Event Description
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Icu medical 131" single lead transfer set 2/clamp, luer lock tubing set leaks after it is attached to iv bag.This has been observed in 6 other sets from the same lot number by the same manufacturer.Fda safety report id# (b)(4).
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