It was reported that there was an issue with jk440 - bottom for 1/1 container height:90mm.According to the complaint description, the silver metallic and black particles were noticed at the bottom of the instrument trays after the steam sterilization cycle.And in the chamber of the units.There was signifiant surgery delay, but it was found in sterile processing before the start of the operation.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Involved components: jk489 - full-size lid w/retention plate silver - lot unknown.Jf949 - silicone cushioning pad 1/1 size - lot unknown.Jm020 - extra long mini cont.Lid non anodized - lot unknown.Jm021 - extra long mini cont.Bottom non anodized - lot unknown.
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Investigation results: visual investigation: the investigation was carried out visually and microscopically with the digital microscope and the digital-camera.We made a visual inspection of the products.Here we detected black flakes, unknown residues, coatings and silicates, metallic particles and scratches on the surface.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.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4 (5) probability of occurrence2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures/preventive measures: according to the quality standard a material defect and a production error can be excluded.Investigation leads to the assumption that the cause for the mentioned deviation most probably was caused by an improper handling.There is the possibility that the black flakes was caused by filter wear due to an improper loading of the container.If the container is heavy loaded there is the possibility that the filter holders start chafe.For this reason, among others, a medical grade plastic was selected for the closure mechanisms.Furthermore, the load that has been sterilized in the container may have cause the deviation described.Based upon the investigations results a capa is not necessary.
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