Catalog Number 515105 |
Device Problem
Moisture Damage (1405)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.Device expiration date: unknown.Device manufacture date: 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 a bd phaseal¿ protector p50 had precipitate on the system.This condition could lead to leakage.There was no report of exposure, serious injury or medical intervention.
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Event Description
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It was reported that a bd phaseal protector p50 had precipitate on the system.This condition could lead to leakage.There was no report of exposure, serious injury or medical intervention.
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Manufacturer Narrative
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As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.During the manufacturing process, visual inspections and critical tests are performed to ensure that the product is within specification.As there is no lot, retained samples cannot be evaluated and dhr cannot be reviewed.No root cause has been established based on the information provided.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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