Samples received: initially (on 08.03.2017) received three open packs (samples from this complaint and also 400335676) but only the aluminum pouch, the support card was not present and thus more samples were requested.On 27.03.2017 54 closed pouches and 4 open were received.Analysis and results: there are two complaints of this reference and batch (this and 400335676).Manufactured and distributed (b)(4) in the market, all to (b)(4).There are no units in stock.The four open units were opened at (b)(4) to check the product, all four units had the support cardboard incorrectly placed in the pack.Have opened all closed samples received and in 21 of the 54 closed units received the support cardboard is placed in inverted position inside the aluminum pack.Due to this fact, the sutures cannot be pulled out from the pack.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill b.Braun surgical requirements.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.Moreover, the personnel involved in the manufacturing of this product will be warned of this issue.
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