Catalog Number 394945 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Information (3190)
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Event Date 03/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the connecta plus3 7 cm white blend experienced leakage.The following information was provided by the customer: during the infusion a fluid leak was detected from injection.
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Manufacturer Narrative
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Investigation: a device history review was conducted for lot number 8250928.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, our engineers were unable to duplicate this event through the leakage testing of the submitted device.However based on previous investigations into this issue and a subsequent review of our manufacturing line determined that the most likely root cause for this event is an abnormality in the equipment responsible for tubing assembly.Capa#629955 was opened.Based on investigation results to date, for leakage issue (in injection valve) root cause was associated to a bad tubing assembly by station 5 of equipment vh59.
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Event Description
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It was reported that the connecta plus3 7 cm white blend experienced leakage.The following information was provided by the customer: during the infusion a fluid leak was detected from injection.
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Search Alerts/Recalls
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