The review of historical data indicated that no other similar complaint concerning an inner lid not completely sealed was reported on the same sterilization lot.The device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.The involved product was returned to intervascular and was visually inspected by our quality assurance supervisor.His observations are as follows: "the product arrived in its box but damaged and torn.The outer lid is open, the inner lid is partially open.There is a match between the product, the labelling of the box and the patient set.After manual peeling of the inner lid of the blister, it appears that the sealing area is 100% visible without defect found according to the internal list of acceptance/rejection criteria for primary packaging (b)(4).This whitish area confirms that the transfer between the coating of the lids and the blisters was 100% done on the sealing area because, if this was not the case, we would have transparent areas on the sealing area." the cause of the event remains unknown.However, the conducted investigation and inspection performed suggest that the product was not defective.
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