Catalog Number 394995 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Information (3190)
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Event Date 11/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.(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 during use of the bd connecta¿ stopcock there was an issue with leakage.
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Manufacturer Narrative
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Investigation summary: a device history review was conducted for lot number 8093934.Our records show the reported lot was manufactured on 04/19/2018, and determined that this is the only instance of leakage occurring in this batch of connecta.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.Investigation conclusion: the sample that was submitted by the facility was subjected to leakage testing; the results from this experiment were unable to identify any leaks in the device that would have originated under product specifications.Root cause description: based on the investigation, the root cause for this complaint could not be determined at the conclusion of the review.Rationale: bd will continue to track and trend for this issue.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.
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Event Description
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It was reported that during use of the bd connecta¿ stopcock there was an issue with leakage.
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Search Alerts/Recalls
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