Catalog Number 394600 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Extubate (2402); Low Oxygen Saturation (2477)
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Event Date 01/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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 bd connecta¿ stopcock leaked during use, causing the patient to "wake up with hypertension, desaturation, extubation risk and hemodynamic alteration".However, there was no medical intervention reported.This event was reported to have occurred twice, but the specific patient data and/or date/time is unknown.
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Event Description
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It was reported that the bd connecta¿ stopcock leaked during use, causing the patient to "wake up with hypertension, desaturation, extubation risk and hemodynamic alteration".However, there was no medical intervention reported.This event was reported to have occurred twice, but the specific patient data and/or date/time is unknown.
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Manufacturer Narrative
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H.6.Investigation: in response to the event reported by your facility a device history review was conducted for lot number 8256665.Our records show that this is the only instance of leakage occurring in this batch of bd 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.Additionally the sample submitted by your facility was subjected to leakage testing and found to be operating within product specifications, exhibiting no signs of leakage or other non-conformances.Unfortunately without the ability to duplicate or observe the reported failure mode, the root cause for this complaint could not be determined at the conclusion of our review.Bd was not able to duplicate or confirm the customer¿s indicated failure mode.
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Search Alerts/Recalls
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