Catalog Number 309657 |
Device Problem
Air Leak (1008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/10/2018 |
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.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Event Description
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It was reported that there is a problem with the plynger or the hub of a 3 ml bd luer-lok¿ disposable syringe with bd luer-lok¿ tip, as it is drawing back air when used during venipuncture.There was no report of exposure, injury or medical intervention.
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Manufacturer Narrative
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Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Since the lot number is unknown, we were unable to examine the device history record.No root cause can be determined as no samples were received.No capa is required.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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