Model Number JS340 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with a container bottom.According to the complaint description, it was reported that white powder was inside and outside of container.There was no described patient harm.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00755 (b)(4).
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Manufacturer Narrative
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Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file - no malfunction or serious injury.Investigation results: visual investigation: the products arrived in a decontaminated condition with whitish-gray corrosion.The investigation was carried out visually and microscopically.Here we detected a whitish gray corrosion of the product.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a product safety case (psc) was initiated.Any action regarding capa will be addressed with this case.
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Event Description
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Associated medwatch-reports: 9610612-2020-00754 (400487385 - js340), 9610612-2020-00755 (400487386 - js389).
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Search Alerts/Recalls
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