Catalog Number 381023 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/13/2018 |
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.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 with the use of the bd insyte¿ autoguard¿ bc shielded iv catheter there was an issue with foreign matter and mold.
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Manufacturer Narrative
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Investigation summary: dhr-the lot number was built / packaged on afa line 12 from 19april2018 thru 22april2018.Review disclosed one non-related qn ((b)(4)-cooling water oos) was initiated during the build of this lot, disposition, corrective action and root cause were applied per quality control plan all other challenge, set-up and in process samples were performed and all passed per specifications.Received 44 iag bc 22ga packages within a dispenser from lot 8107798.All of the contents within were intact.Visual/microscopic evaluation: 3 of the units received had traces of soiled packaging trim caught on the seal of the packages.The remainder of the packages did not reveal any fm related defects.Ftir test was performed (franklin lakes) confirming the material observed is lubrication used on the machines as part of preventive maintenance.Manufacturing ¿ packaging: the packaging trim was not removed by the removal vacuum.If the package trim is not removed it goes around the machine coming into contact with pm lube and continues around into the seal.
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Event Description
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It was reported with the use of the bd insyte¿ autoguard¿ bc shielded iv catheter there was an issue with foreign matter and mold.
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Search Alerts/Recalls
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