(b)(4).The device history records (lot 12ce14, 11ge32 & 121e40) were reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.From visual observation on the representative samples, no issue was found.All components were intact and in good condition.Based on the report statement, a catheter was found broken at the junction of the tube, a day after insertion.To confirm device is functioning well, funnel detachment test was conducted to determine the bonding strength between funnel and shaft of the representative sample.In addition, (b)(4) pieces of production samples inclusive of representative samples were picked for funnel detachment test.Based on the findings, all tested samples met the minimum requirement of 7.5n and no other findings within the product, which could have contributed from manufacturing processes.In the absence of the actual samples, we could not conduct further investigation to associate the nature of the failure with any manufacturing inadequacy.Therefore this complaint is not confirmed.
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