Country of complaint: (b)(6).Complaint states: there are two different problems at this product.One, the withdrawal of the needle is very heavy.You have the feeling that the package is chamber to the back.Due to this you couldn't grab the needle correctly.Two, the withdrawal of the needle is too strong.Due to this, the thread broke very easily during the withdrawal.
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Us reporting agent notified on: (b)(4) 2014.Manufacturing site evaluation: samples received: one unopened racepack.There are no previous complaints of this code batch.There are no units in oem stock.The withdrawal of the needle has been correct and the usual one.After holding the needle, the suture has been pulled out from the pack without difficulty and the usual one.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill oem requirements.Final conclusion: the complaint is not corresponding (not justified).Corrective/preventive actions: not applicable.
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