(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination in the coming days.(4109/3233) the review of historical data indicated that another similar complaint was reported for the same lot 17m07 and the same product reference.The second case comes from the same hospital (complaint #392595).The investigation is ongoing.(3331/213) the device history records review concluded that there is no non-conformance / planned deviation in relation with the event reported.(11/213) two retention samples were selected based on the following criteria: -one was coming from the same sterilization lot and was coated on the same day and under similar conditions as the involved device of complaint 392594 --one was coming from the same sterilization lot and was coated on the same day and under similar conditions as the involved device of complaint 392595 during the complaint investigation, these retention samples were visually inspected by the quality assurance supervisor, inspection of packaging components included.No stain was found on the internal and external primary packaging of the retention samples.The products and packaging are in compliance with specification.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
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(10/193) the involved product was returned to intervascular and was inspected by our quality assurance (qa) supervisor.His observations are as follows: "the product arrived in its box but damaged.The external and internal lids were not open.There is a match between the product, the labelling of the box and the patient set.After manual peeling of the internal blister lid, it appears that yellow halos are visible on the lid corresponding to the location of the product in the internal blister.The product does not present any apparent collagen excess defect (collagen excess internal and external) according to our internal specifications.In addition, a visual inspection of the primary packaging, including the sealing strip, the shells and the lid, is performed on each packaged product with the criterion "stain embedded in the inner lid" as a defect standard, with an acceptability limit of < 0.2 mm² in accordance with internal specifications.If this stain was present during the primary packaging of this product it would have been rejected during the control of this packaging to be repackaged, we cannot therefore rule on the origin of the defect other than inadequate storage conditions by our various stakeholders." (11/213) as an additional investigation since the initial mdr, another retention sample was selected based on the following criteria: same sterilization lot, coated one day before the involved device of complaint (b)(4) and seven days before the involved device of complaint (b)(4).Product configuration closer than the previous retention samples selected for the initial mdr.This new selected retention sample was visually inspected by the quality assurance supervisor, including the control of packaging components.No stain was found on the internal and external primary packaging of the retention samples.The product and his packaging are in compliance with the specifications.(4109/193) the review of historical data indicated that one other similar complaint (#(b)(4)) was reported for the same lot 17m07 and the same product reference.The second case (complaint #(b)(4)) comes from the same hospital and has an identical logistical traceability.The visual inspection of the returned product for complaint #(b)(4)concluded that the product was also defective probably due to inappropriate storage conditions.Therefore, we can assume that both products are defective probably due to inappropriate storage conditions applied for these two products by the various stakeholders.(4308) the outcome of our investigation, which included all available information and the testing we performed, suggests that the returned graft was not defective at the time of manufacturing.The most probable cause of the defect is inadequate storage of the device by the various stakeholders.An internal non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.
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