Model Number JK095 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/31/2021 |
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 jk095 - single use paper filter with indicator according to the complaint description, the 3 boxes having been autoclaved on two different days in sterilization have paper filters that do not conform.There are micro holes on all the filters.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00458 (400515982 - jk095).9610612-2021-00462 (400516336 - jk095).
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Manufacturer Narrative
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Additional information: based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file no malfunction or serious injury.No failure was detected during investigation the devicce function as intended.
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Manufacturer Narrative
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Investigation results: visual investigation the product received us in an decontaminated condition.There was no deviation or micro holes could be detected.Furthermore the products were sent to the manufacturer for further analysis.Based on the analysis there are no holes could be detected as well.The marked areas are thin spots which cannot be avoided during the production of the raw material.Additionally the external laboratory confirms that germ-tightness is ensured at the thin spots.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.Conclusion and measures / preventive measures: there is no indication for a material-, manufacturing- or design-related failure.There was no product deviation founded.Based upon the investigations results a capa is not necessary.
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Search Alerts/Recalls
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