Model Number A2-80072 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Not Applicable (3189)
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Event Date 02/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer is currently waiting for the arrival of the iv set.
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Event Description
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The user reported leakage of the iv set.No patient harm or injury occurred in this case.
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Manufacturer Narrative
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The user-reported leaking issue was not confirmed.Zyno medical performed testings on 10 unopened samples of returned iv set with the same lot number on 06/14/2017, and the investigation report is attached.(b)(4).
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Event Description
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This is a follow-up for the initially filed mdr (3006575795-2017-00070).
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Search Alerts/Recalls
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