Catalog Number 394945 |
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 10/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd connecta¿ stopcock leaked.This occurred on 2 occasions during use.The following information was provided by the initial reporter: when used it is being filtered by the filter plug that is close to the key.Additional information: the exposure of blood was minor because the professional was using gloves and the blood was only leaked in the filter plug of the product.
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Manufacturer Narrative
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Investigation: a device history review was conducted for lot number 8180509.Our records show that this is the only instance of this issue occurring in this production batch.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.Although photos were submitted for evaluation, they did not display the failure mode clearly enough to identify the root cause.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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Event Description
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It was reported that bd connecta¿ stopcock leaked.This occurred on 2 occasions during use.The following information was provided by the initial reporter: when used it is being filtered by the filter plug that is close to the key.Additional information: the exposure of blood was minor because the professional was using gloves and the blood was only leaked in the filter plug of the product.
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Search Alerts/Recalls
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