Catalog Number 394971 |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/25/2019 |
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.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9092971.Medical device expiration date: 2022-03-31.Device manufacture date: 2019-05-07.Medical device lot #: 9116511.Medical device expiration date: 2022-03-31.Device manufacture date: 2019-05-14.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 has been reported that the bd connecta¿ stopcock has been found with air in the line during use.The following has been provided by the initial reporter: air flow through the extension valve during a bypass infusion.Another valve was installed, no consequence on the patient.
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Event Description
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It has been reported that the bd connecta¿ stopcock has been found with air in the line during use.The following has been provided by the initial reporter: air flow through the extension valve during a bypass infusion.Another valve was installed, no consequence on the patient.
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Manufacturer Narrative
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H.6.Investigation: a device history record review was performed for provided lot numbers 8338961, 9092971, and 9116511.The review did not reveal any detected quality issues during the production process that could have contributed to the reported incident.To further investigate this issue, one sample belonging to lot number 8338961 was received for evaluation by our quality team.The sample was used and the fitting was placed into the housing incorrectly, which prevented it from being disconnected from the device.The sample was functionally tested and the reported incident could not be replicated.Based on the investigation results, a manufacturing related cause could not be determined for this incident.
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Search Alerts/Recalls
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