Catalog Number 394971 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
Pulmonary Embolism (1498)
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Event Date 01/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8184942; medical device expiration date: 2021-06-30; device manufacture date: 2018-08-29; medical device lot #: 7181507; medical device expiration date: 2020-05-31; device manufacture date: 2017-07-20.Date of event: unknown.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 there were +/- 30 incidents were a bd connecta¿ stopcock with valve & extension tubing leaked during use.It was also reported that one patient suffered a pulmonary embolism due to air related to the leakage.It is unknown if medical interventions were provided or if there was a change in treatment for this patient.
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Manufacturer Narrative
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H.6.Investigation: a device history review was conducted for lot number 8213741 and 7181507.Our records show that this is the only instance of this issue occurring in either 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.Additionally, our engineers were able to duplicate this event through the leakage testing of the submitted device.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.
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Event Description
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It was reported that there were +/- 30 incidents were a bd connecta¿ stopcock with valve & extension tubing leaked during use.It was also reported that one patient suffered a pulmonary embolism due to air related to the leakage.It is unknown if medical interventions were provided or if there was a change in treatment for this patient.
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Search Alerts/Recalls
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